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  </head><body onload="reset_menus();"><div id="menu"><a name="top" class="invisible" href="#main">Skip Navigation Link</a><span class="study-name">TDF_ADaM</span><ul class="hmenu"><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a class="tocItem">Supplemental Documents</a><ul><li class="hmenu-item"><span class="hmenu-bullet">+</span><a class="external tocItem" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span></li><li class="hmenu-item"><span class="hmenu-bullet">+</span><a class="external tocItem" href="complex-algorithms-example.pdf">Complex Alogrithm Example</a><span class="external-link-gif"></span></li></ul></li><li class="hmenu-item"><span class="hmenu-bullet" onclick="toggle_submenu(this);">-</span><a class="tocItem" href="#Standards_Table">Standards</a></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#ARM_Table_Summary">Analysis Results Metadata</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#ARD.RD.Table14.3.01" title="Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF">Table14.3.01</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#ARD.RD.Table14.5.02" title="Incidence of Treatment Emergent Serious Adverse Events by Treatment Group">Table14.5.02</a></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#datasets">Datasets</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADSL">ADSL (Subject-Level Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADADAS">ADADAS (ADAS-Cog Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADCIBC">ADCIBC (CIBIC+ Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADLBC">ADLBC (Analysis Dataset Lab Blood Chemistry)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADLBCPV">ADLBCPV (Analysis Dataset Lab Blood Chemistry (Previous Visit))</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADLBH">ADLBH (Analysis Dataset Lab Hematology)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADLBHPV">ADLBHPV (Analysis Dataset Lab Hematology (Previous Visit))</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADLBHY">ADLBHY (Analysis Dataset Lab Hy's Law)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADNPIX">ADNPIX (NPI-X Item Analysis Data)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADTTE">ADTTE (AE Time To 1st Derm. Event Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADVS">ADVS (Vital Signs Analysis Dataset)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.ADAE">ADAE (Adverse Events Analysis Dataset)</a></li></ul></li><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a href="#decodelist" class="tocItem">Controlled Terminology</a><ul><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#decodelist">CodeLists</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADADAS.AVISIT">Analysis Visit (ADADAS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADADAS.AVISITN">Analysis Visit (N) (ADADAS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADADAS.VISIT">Visit (ADADAS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADADAS.VISITNUM">Visit (N) (ADADAS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADCIBC.AVISIT">Analysis Visit (ADCIBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADCIBC.AVISITN">Analysis Visit (N) (ADCIBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADCIBC.VISIT">Visit (ADCIBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADCIBC.VISITNUM">Visit (N) (ADCIBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBC.AVISIT">Analysis Visit (ADLBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBC.AVISITN">Analysis Visit (N) (ADLBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBC.VISIT">Visit (ADLBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBC.VISITNUM">Visit (N) (ADLBC)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBCPV.AVISIT">Analysis Visit (ADLBCPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBCPV.AVISITN">Analysis Visit (N) (ADLBCPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBCPV.VISIT">Visit (ADLBCPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBCPV.VISITNUM">Visit (N) (ADLBCPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBH.AVISIT">Analysis Visit (ADLBH)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBH.AVISITN">Analysis Visit (N) (ADLBH)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBH.VISIT">Visit (ADLBH)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBH.VISITNUM">Visit (N) (ADLBH)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHPV.AVISIT">Analysis Visit (ADLBHPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHPV.AVISITN">Analysis Visit (N) (ADLBHPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHPV.VISIT">Visit (ADLBHPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHPV.VISITNUM">Visit (N) (ADLBHPV)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHY.AVISIT">Analysis Visit (ADLBHY)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHY.AVISITN">Analysis Visit (N) (ADLBHY)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHY.VISIT">Visit (ADLBHY)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADLBHY.VISITNUM">Visit (N) (ADLBHY)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADNPIX.AVISIT">Analysis Visit (ADNPIX)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADNPIX.AVISITN">Analysis Visit (N) (ADNPIX)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADNPIX.VISIT">Visit (ADNPIX)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADNPIX.VISITNUM">Visit (N) (ADNPIX)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.ATPT">Analysis Timepoint (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.ATPTN">Analysis Timepoint (N) (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.AVISIT">Analysis Visit (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.AVISITN">Analysis Visit (N) (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.VISIT">Visit (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ADVS.VISITNUM">Visit (N) (ADVS)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AECAUS">Causality</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AESEV">Severity/Intensity Scale for Adverse Events</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AGEGR1">Age Group 1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AGEU">Age Unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ARM">Planned Arm</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ARMN">Planned Arm (N)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AWU">Analysis Window Unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.BMICAT">BMI Category</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.CENSOR">Censor</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DATEFL">Date Imputation Flag</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DISCCD">Standardized Disposition Term</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DISCREAS">Reason for Discontinuation from Study</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DTYPE">Derivation Type</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.DURDISC">Duration of Disease Category</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.ETHNIC">Ethnicity</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LBNRIND">Reference Range Indicator</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.LNH">Low Normal High</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.OUT">Outcome</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADLBC">PARAM_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADLBCPV">PARAM_ADLBCPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADLBH">PARAM_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADLBHPV">PARAM_ADLBHPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADLBHY">PARAM_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADQSADAS">PARAM_ADQSADAS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADQSCIBC">PARAM_ADQSCIBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADQSNPIX">PARAM_ADQSNPIX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADTTE">PARAM_ADTTE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAM_ADVS">PARAM_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBC">PARAMCD_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBCPV">PARAMCD_ADLBCPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBH">PARAMCD_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBHPV">PARAMCD_ADLBHPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBHY">PARAMCD_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADQSADAS">PARAMCD_ADQSADAS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADQSCIBC">PARAMCD_ADQSCIBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADQSNPIX">PARAMCD_ADQSNPIX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADTTE">PARAMCD_ADTTE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMCD_ADVS">PARAMCD_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADLBC">PARAMN_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADLBCPV">PARAMN_ADLBCPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADLBH">PARAMN_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADLBHPV">PARAMN_ADLBHPV</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADLBHY">PARAMN_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADQSADAS">PARAMN_ADQSADAS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADQSCIBC">PARAMN_ADQSCIBC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADQSNPIX">PARAMN_ADQSNPIX</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMN_ADVS">PARAMN_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.PARAMTYP">PARAMTYP</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RACE">Race</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.RACEN">Race (N)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SEX">Sex</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SHIFT">Shift</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.SHIFTN">Shift (N)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.Y_BLANK">Y Only</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.YN">No Yes Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.YNN">No Yes Response (N)</a></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#externaldictionary">External Dictionaries</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a></li></ul></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#compmethod">Methods</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ABLFL">Algorithm to derive ABLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.ADT">Algorithm to derive ADADAS.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.ANL01FL">Algorithm to derive ADADAS.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AVAL.ACTOT">Algorithm to derive ADADAS.AVAL.ACTOT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AVISIT">Algorithm to derive ADADAS.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWHI">Algorithm to derive ADADAS.AWHI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWLO">Algorithm to derive ADADAS.AWLO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWRANGE">Algorithm to derive ADADAS.AWRANGE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWTARGET">Algorithm to derive ADADAS.AWTARGET</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWTDIFF">Algorithm to derive ADADAS.AWTDIFF</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.AWU">Algorithm to derive ADADAS.AWU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADADAS.BASE">Algorithm to derive ADADAS.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.ADURN">Algorithm to derive ADAE.ADURN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.ADURU">Algorithm to derive ADAE.ADURU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AENDT">Algorithm to derive ADAE.AENDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AENDY">Algorithm to derive ADAE.AENDY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCC01FL">Algorithm to derive ADAE.AOCC01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCC02FL">Algorithm to derive ADAE.AOCC02FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCC03FL">Algorithm to derive ADAE.AOCC03FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCC04FL">Algorithm to derive ADAE.AOCC04FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCCFL">Algorithm to derive ADAE.AOCCFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCCPFL">Algorithm to derive ADAE.AOCCPFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.AOCCSFL">Algorithm to derive ADAE.AOCCSFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.ASTDT">Algorithm to derive ADAE.ASTDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.ASTDTF">Algorithm to derive ADAE.ASTDTF</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.ASTDY">Algorithm to derive ADAE.ASTDY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.CQ01NAM">Algorithm to derive ADAE.CQ01NAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADAE.TRTEMFL">Algorithm to derive ADAE.TRTEMFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.ADT">Algorithm to derive ADCIBC.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.ANL01FL">Algorithm to derive ADCIBC.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AVISIT">Algorithm to derive ADCIBC.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWHI">Algorithm to derive ADCIBC.AWHI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWLO">Algorithm to derive ADCIBC.AWLO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWRANGE">Algorithm to derive ADCIBC.AWRANGE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWTARGET">Algorithm to derive ADCIBC.AWTARGET</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWTDIFF">Algorithm to derive ADCIBC.AWTDIFF</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADCIBC.AWU">Algorithm to derive ADCIBC.AWU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.ADT">Algorithm to derive ADLBC.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.AENTMTFL">Algorithm to derive ADLBC.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.ANL01FL">Algorithm to derive ADLBC.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.ANRIND">Algorithm to derive ADLBC.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.AVISIT">Algorithm to derive ADLBC.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.BASE">Algorithm to derive ADLBC.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.BR2A1HI">Algorithm to derive ADLBC.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.BR2A1LO">Algorithm to derive ADLBC.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.PARAM">Algorithm to derive ADLBC.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.PARAMCD">Algorithm to derive ADLBC.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.R2A1HI">Algorithm to derive ADLBC.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBC.R2A1LO">Algorithm to derive ADLBC.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.ADT">Algorithm to derive ADLBCPV.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.AENTMTFL">Algorithm to derive ADLBCPV.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.ANL01FL">Algorithm to derive ADLBCPV.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.ANRIND">Algorithm to derive ADLBCPV.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.AVAL">Algorithm to derive ADLBCPV.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.AVISIT">Algorithm to derive ADLBCPV.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.BASE">Algorithm to derive ADLBCPV.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.BR2A1HI">Algorithm to derive ADLBCPV.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.BR2A1LO">Algorithm to derive ADLBCPV.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.PARAM">Algorithm to derive ADLBCPV.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.PARAMCD">Algorithm to derive ADLBCPV.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.R2A1HI">Algorithm to derive ADLBCPV.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBCPV.R2A1LO">Algorithm to derive ADLBCPV.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.ADT">Algorithm to derive ADLBH.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.AENTMTFL">Algorithm to derive ADLBH.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.ANL01FL">Algorithm to derive ADLBH.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.ANRIND">Algorithm to derive ADLBH.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.AVISIT">Algorithm to derive ADLBH.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.BASE">Algorithm to derive ADLBH.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.BR2A1HI">Algorithm to derive ADLBH.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.BR2A1LO">Algorithm to derive ADLBH.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.PARAM">Algorithm to derive ADLBH.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.PARAMCD">Algorithm to derive ADLBH.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.R2A1HI">Algorithm to derive ADLBH.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBH.R2A1LO">Algorithm to derive ADLBH.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.ADT">Algorithm to derive ADLBHPV.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.AENTMTFL">Algorithm to derive ADLBHPV.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.ANL01FL">Algorithm to derive ADLBHPV.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.ANRIND">Algorithm to derive ADLBHPV.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.AVAL">Algorithm to derive ADLBHPV.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.AVISIT">Algorithm to derive ADLBHPV.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.BASE">Algorithm to derive ADLBHPV.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.BR2A1HI">Algorithm to derive ADLBHPV.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.BR2A1LO">Algorithm to derive ADLBHPV.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.PARAM">Algorithm to derive ADLBHPV.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.PARAMCD">Algorithm to derive ADLBHPV.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.R2A1HI">Algorithm to derive ADLBHPV.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHPV.R2A1LO">Algorithm to derive ADLBHPV.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.ADT">Algorithm to derive ADLBHY.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.AVAL.BILIHY">Algorithm to derive ADLBHY.AVAL.BILIHY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.AVAL.HYLAW">Algorithm to derive ADLBHY.AVAL.HYLAW</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.AVAL.TRANSHY">Algorithm to derive ADLBHY.AVAL.TRANSHY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.AVISIT">Algorithm to derive ADLBHY.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.BASE">Algorithm to derive ADLBHY.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.CRIT1FL">Algorithm to derive ADLBHY.CRIT1FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADLBHY.PARAM">Algorithm to derive ADLBHY.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.ADT">Algorithm to derive ADNPIX.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.ANL01FL">Algorithm to derive ADNPIX.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AVAL.NPTOTMN">Algorithm to derive ADNPIX.AVAL.NPTOTMN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AVISIT">Algorithm to derive ADNPIX.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWHI">Algorithm to derive ADNPIX.AWHI</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWLO">Algorithm to derive ADNPIX.AWLO</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWRANGE">Algorithm to derive ADNPIX.AWRANGE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWTARGET">Algorithm to derive ADNPIX.AWTARGET</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWTDIFF">Algorithm to derive ADNPIX.AWTDIFF</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.AWU">Algorithm to derive ADNPIX.AWU</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADNPIX.BASE">Algorithm to derive ADNPIX.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.AGEGR1">Algorithm to derive ADSL.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.AGEGR1N">Algorithm to derive ADSL.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.AVGDD">Algorithm to derive ADSL.AVGDD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.BMIBL">Algorithm to derive ADSL.BMIBL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.BMIBLGR1">Algorithm to derive ADSL.BMIBLGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.COMP16FL">Algorithm to derive ADSL.COMP16FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.COMP24FL">Algorithm to derive ADSL.COMP24FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.COMP8FL">Algorithm to derive ADSL.COMP8FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.CUMDOSE">Algorithm to derive ADSL.CUMDOSE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DCDECOD">Algorithm to derive ADSL.DCDECOD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DCREASCD">Algorithm to derive ADSL.DCREASCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DISCONFL">Algorithm to derive ADSL.DISCONFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DISONSDT">Algorithm to derive ADSL.DISONSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DSRAEFL">Algorithm to derive ADSL.DSRAEFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DURDIS">Algorithm to derive ADSL.DURDIS</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.DURDSGR1">Algorithm to derive ADSL.DURDSGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.EDUCLVL">Algorithm to derive ADSL.EDUCLVL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.EFFFL">Algorithm to derive ADSL.EFFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.EOSSTT">Algorithm to derive ADSL.EOSSTT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.HEIGHTBL">Algorithm to derive ADSL.HEIGHTBL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.ITTFL">Algorithm to derive ADSL.ITTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.MMSETOT">Algorithm to derive ADSL.MMSETOT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.RACEN">Algorithm to derive ADSL.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.RFENDT">Algorithm to derive ADSL.RFENDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.SAFFL">Algorithm to derive ADSL.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.SITEGR1">Algorithm to derive ADSL.SITEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRT01A">Algorithm to derive ADSL.TRT01A</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRT01AN">Algorithm to derive ADSL.TRT01AN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRT01PN">Algorithm to derive ADSL.TRT01PN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRTDUR">Algorithm to derive ADSL.TRTDUR</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRTEDT">Algorithm to derive ADSL.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.TRTSDT">Algorithm to derive ADSL.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.VISIT1DT">Algorithm to derive ADSL.VISIT1DT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.VISNUMEN">Algorithm to derive ADSL.VISNUMEN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADSL.WEIGHTBL">Algorithm to derive ADSL.WEIGHTBL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.ADT">Algorithm to derive ADTTE.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.AVAL">Algorithm to derive ADTTE.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.CNSR">Algorithm to derive ADTTE.CNSR</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.EVNTDESC">Algorithm to derive ADTTE.EVNTDESC</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.SRCDOM">Algorithm to derive ADTTE.SRCDOM</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.SRCSEQ">Algorithm to derive ADTTE.SRCSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADTTE.SRCVAR">Algorithm to derive ADTTE.SRCVAR</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADVS.ADT">Algorithm to derive ADVS.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADVS.ANL01FL">Algorithm to derive ADVS.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADVS.AVISIT">Algorithm to derive ADVS.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADVS.BASE">Algorithm to derive ADVS.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ADY">Algorithm to derive ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.ALBTRVAL">Algorithm to derive ALBTRVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.AVISITN">Algorithm to derive AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.BNRIND">Algorithm to derive BNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.CHG">Algorithm to derive CHG</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.DTYPE">Algorithm to derive DTYPE</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.PCHG">Algorithm to derive PCHG</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.SHIFT1">Algorithm to derive SHIFT1</a></li></ul></li></ul><div class="buttons"><div class="button"><button type="button" onclick="expand_all_vlm();">Expand all VLM</button></div><div class="button"><button type="button" onclick="collapse_all_vlm();">Collapse all VLM</button></div></div></div><div id="main"><div class="docinfo"><p class="documentinfo">Date/Time of Define-XML document generation: 2022-07-22T16:50:56-05:00</p><p class="documentinfo">Define-XML version: 2.1.0</p><p class="documentinfo">Define-XML Context: Submission</p><p class="stylesheetinfo">Stylesheet version: 2019-02-11</p></div><div class="study-metadata"><dl class="study-metadata"><dt>Study Name</dt><dd>TDF_ADaM</dd><dt>Study Description</dt><dd>Test datasets created by updating existing CDISCPILOT ADaM datasets</dd><dt>Protocol Name</dt><dd>TDF_Datasets</dd><dt>Metadata Name</dt><dd>Study TDF_ADaM Data Definitions</dd></dl></div><h1 class="invisible">Standards for Study TDF_ADaM</h1><div class="containerbox"><table id="Standards_Table" summary="Standards"><caption class="header">Standards for Study TDF_ADaM</caption><tr class="header"><th scope="col">Standard</th><th scope="col">Type</th><th scope="col">Status</th><th scope="col">Documentation</th></tr><tr class="tablerowodd" id="STD.STD.ADaMIG 1.1"><td>ADaMIG 1.1</td><td>IG</td><td>FINAL</td><td></td></tr><tr class="tableroweven" id="STD.STD.ADaM 2020-12-18"><td>CDISC/NCI ADaM 2020-12-18</td><td>CT</td><td>FINAL</td><td></td></tr><tr class="tablerowodd" id="STD.STD.SDTM 2020-12-18"><td>CDISC/NCI SDTM 2020-12-18</td><td>CT</td><td>FINAL</td><td></td></tr><tr class="tableroweven" id="STD.STD.DEFINE-XML"><td>CDISC/NCI DEFINE-XML 2020-12-18</td><td>CT</td><td>FINAL</td><td></td></tr></table></div><br><div class="containerbox"><h1 id="ARM_Table_Summary">Analysis Results Metadata - Summary</h1><div class="arm-summary"><div class="arm-summary-resultdisplay"><a href="#ARD.RD.Table14.3.01">Table14.3.01</a><span class="arm-display-title">Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF</span><p class="arm-summary-result"><a href="#AR.AR.Table14.3.01.AR.0000">Dose response analysis for ADAS-Cog changes from Baseline</a></p></div><div class="arm-summary-resultdisplay"><a href="#ARD.RD.Table14.5.02">Table14.5.02</a><span class="arm-display-title">Incidence of Treatment Emergent Serious Adverse Events by Treatment Group</span><p class="arm-summary-result"><a href="#AR.AR.Table14.5.02.AR.0000">Get denominators for precentages from ADSL and counts and numerators from ADAE. Join ADAE with ADSL based on USUBJID keeping only records in ADAE for the numerator.</a></p></div></div></div><br><h1>Analysis Results Metadata - Detail</h1><div class="containerbox"><a id="ARD.RD.Table14.3.01"></a><table class="analysisresults-detail" summary="Analysis Results Metadata - Detail"><caption>Table14.3.01</caption><tr><th scope="col" class="arm-resultlabel">Display</th><th scope="col"> <span class="arm-displaytitle">Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF</span></th></tr><tr class="arm-analysisresult"><td>Analysis Result</td><td><span class="arm-resulttitle" id="AR.AR.Table14.3.01.AR.0000">Dose response analysis for ADAS-Cog changes from Baseline</span></td></tr><tr><td class="arm-label">Analysis Parameter(s)</td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACTOT" (Adas-Cog(11) Subscore)<br></td></tr><tr><td class="arm-label">Analysis Variable(s)</td><td><p class="arm-analysisvariable"><a href="#IG.ADADAS">ADADAS</a>.<a href="#IG.ADADAS.IT.ADADAS.AVAL">AVAL</a> (Analysis Value)
                              
                            </p><p class="arm-analysisvariable"><a href="#IG.ADADAS">ADADAS</a>.<a href="#IG.ADADAS.IT.ADADAS.CHG">CHG</a> (Change from Baseline)
                              
                            </p></td></tr><tr><td class="arm-label">Analysis Reason</td><td>SPECIFIED IN PROTOCOL</td></tr><tr><td class="arm-label">Analysis Purpose</td><td>PRIMARY OUTCOME MEASURE</td></tr><tr><td class="arm-label">Data References (incl. Selection Criteria)</td><td><div class="arm-data-reference"><a href="#IG.ADADAS" title="ADAS-Cog Analysis">ADADAS</a>  [<a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACTOT" and <a href="#IG.ADADAS.IT.ADADAS.AVISITN" title="Analysis Visit (N)">AVISITN</a> = 24 and <a href="#IG.ADADAS.IT.ADADAS.EFFFL" title="Efficacy Population Flag">EFFFL</a> = "Y"]</div></td></tr><tr><td class="arm-label">Documentation</td><td><span>Accordingly, the dose response for the change from baseline at Week 24,
adjusted for site and baseline score is not statistically significantly different from 0.
Pairwise comparisons among the treatment groups are also presented.</span></td></tr><tr><td class="arm-label">Programming Statements</td><td><span class="arm-code-context">[SAS Version 9.4]</span><pre class="arm-code">proc glm data= adadas;
where EFFFL01 = 'Y' and ANL01FL = "Y" and AVISIT = "Week 24" and PARAMCD ='ACTOT';
class SITEGR1;
model chg = TRTPN SITEGR1;
run;</pre><div class="arm-code-ref"></div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><div class="containerbox"><a id="ARD.RD.Table14.5.02"></a><table class="analysisresults-detail" summary="Analysis Results Metadata - Detail"><caption>Table14.5.02</caption><tr><th scope="col" class="arm-resultlabel">Display</th><th scope="col"> <span class="arm-displaytitle">Incidence of Treatment Emergent Serious Adverse Events by Treatment Group</span></th></tr><tr class="arm-analysisresult"><td>Analysis Result</td><td><span class="arm-resulttitle" id="AR.AR.Table14.5.02.AR.0000">Get denominators for precentages from ADSL and counts and numerators from ADAE. Join ADAE with ADSL based on USUBJID keeping only records in ADAE for the numerator.</span></td></tr><tr><td class="arm-label">Analysis Parameter(s)</td><td></td></tr><tr><td class="arm-label">Analysis Variable(s)</td><td><p class="arm-analysisvariable"><a href="#IG.ADAE">ADAE</a>.<a href="#IG.ADAE.IT.ADAE.AEDECOD">AEDECOD</a> (Dictionary-Derived Term)
                              
                            </p></td></tr><tr><td class="arm-label">Analysis Reason</td><td>SPECIFIED IN PROTOCOL</td></tr><tr><td class="arm-label">Analysis Purpose</td><td>SECONDARY OUTCOME MEASURE</td></tr><tr><td class="arm-label">Data References (incl. Selection Criteria)</td><td><div class="arm-data-reference"><a href="#IG.ADAE" title="Adverse Events Analysis Dataset">ADAE</a>  [<a href="#IG.ADAE.IT.ADAE.AESER" title="Serious Event">AESER</a> = "Y" and <a href="#IG.ADAE.IT.ADAE.SAFFL" title="Safety Population Flag">SAFFL</a> = "Y"]</div></td></tr><tr><td class="arm-label">Documentation</td><td><span>Summarization at the subject, System Organ Class, and Preferred Term levels, respectively.</span></td></tr><tr><td class="arm-label">Programming Statements</td><td><span class="arm-code-context">[SAS Version 9.4]</span><pre class="arm-code">** INFERENTIAL STATISTICS **;
** PT LEVEL **;
proc sql;
create table BACKBONE as select * from
(select distinct USUBJID, TRT01AN as TRTAN from ADSL(where=(SAFFL='Y'))) ,
(select distinct AEDECOD from ADAE(where=(TRTEMFL='Y' and AESER='Y')));
create table HADEVENT as select distinct STUDYID, USUBJID, TRTAN, AEDECOD
from ADAE(where=(TRTEMFL='Y' and AESER='Y'));

create table FISHER as select a.USUBJID, a.TRTAN, a.AEDECOD,
case when STUDYID='CDISCPILOT01' then 1
else 0
end as EVENT
from BACKBONE a left join HADEVENT b
on a.USUBJID=b.USUBJID and a.TRTAN=b.TRTAN and a.AEDECOD=b.AEDECOD
order by a.AEDECOD, a.TRTAN;
quit;
** HIGH DOSE VERSUS PLACEBO **;
proc freq data=FISHER; 
by AEDECOD; 
where TRTAN in (0,2);
table TRTAN*EVENT/exact; 
ods output FishersExact=F1PT(where=(Name1='XP2_FISH'));
run;
** LOW DOSE VERSUS PLACEBO **;
proc freq data=FISHER; 
by AEDECOD; 
where TRTAN in (0,1);
table TRTAN*EVENT/exact; 
ods output FishersExact=F2PT(where=(Name1='XP2_FISH'));
run;</pre><div class="arm-code-ref"></div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><br><a id="datasets"></a><h1 class="invisible">Datasets</h1><div class="containerbox"><table summary="Data Definition Tables"><caption class="header">Datasets</caption><tr class="header"><th scope="col">Dataset</th><th scope="col">Description</th><th scope="col">Class
            
             - SubClass</th><th scope="col">Structure</th><th scope="col">Purpose</th><th scope="col">Keys</th><th scope="col">Documentation</th><th scope="col">Location</th></tr><tr class="tablerowodd" id="IG.ADSL"><td><a href="#IG.IG.ADSL">ADSL</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Subject-Level Analysis</td><td>SUBJECT LEVEL ANALYSIS DATASET</td><td>one record per subject</td><td>Analysis</td><td>USUBJID</td><td><p class="linebreakcell">See ADRG Section 5.2.1 ADSL - Subject Level Analysis Dataset for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adsl.xpt">adsl.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADADAS"><td><a href="#IG.IG.ADADAS">ADADAS</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>ADAS-Cog Analysis</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit per analysis date</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, ADT</td><td><p class="linebreakcell">See ADRG Section 5.2.2 ADADAS - ADAS-Cog Analysis for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adadas.xpt">adadas.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADCIBC"><td><a href="#IG.IG.ADCIBC">ADCIBC</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>CIBIC+ Analysis</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit per analysis date</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, ADT</td><td><p class="linebreakcell">See ADRG Section 5.2.4 ADCIBC - CIBIC+ Analysis for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adcibc.xpt">adcibc.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADLBC"><td><a href="#IG.IG.ADLBC">ADLBC</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Analysis Dataset Lab Blood Chemistry</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td><p class="linebreakcell">See ADRG Section 5.2.5 ADLBC - Analysis Dataset Lab Blood Chemistry for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adlbc.xpt">adlbc.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADLBCPV"><td><a href="#IG.IG.ADLBCPV">ADLBCPV</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Analysis Dataset Lab Blood Chemistry (Previous Visit)</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td></td><td><a class="external" href="adlbcpv.xpt">adlbcpv.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADLBH"><td><a href="#IG.IG.ADLBH">ADLBH</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Analysis Dataset Lab Hematology</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td><p class="linebreakcell">See ADRG Section 5.2.5 ADLBH - Analysis Dataset Lab Hematalogy for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adlbh.xpt">adlbh.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADLBHPV"><td><a href="#IG.IG.ADLBHPV">ADLBHPV</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Analysis Dataset Lab Hematology (Previous Visit)</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td></td><td><a class="external" href="adlbhpv.xpt">adlbhpv.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADLBHY"><td><a href="#IG.IG.ADLBHY">ADLBHY</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Analysis Dataset Lab Hy's Law</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT</td><td><p class="linebreakcell">See ADRG Section 5.2.5 ADLBHY - Analysis Dataset Lab Hy's Law for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adlbhy.xpt">adlbhy.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADNPIX"><td><a href="#IG.IG.ADNPIX">ADNPIX</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>NPI-X Item Analysis Data</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit per analysis date</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, ADT</td><td><p class="linebreakcell">See ADRG Section 5.2.5 ADNPIX - NPI-X Item Analysis Dataset for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adnpix.xpt">adnpix.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADTTE"><td><a href="#IG.IG.ADTTE">ADTTE</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>AE Time To 1st Derm. Event Analysis</td><td>BASIC DATA STRUCTURE<ul class="SubClass"><li class="SubClass">TIME-TO-EVENT</li></ul></td><td>one record per subject per parameter</td><td>Analysis</td><td>USUBJID, PARAMCD</td><td></td><td><a class="external" href="adtte.xpt">adtte.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADVS"><td><a href="#IG.IG.ADVS">ADVS</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Vital Signs Analysis Dataset</td><td>BASIC DATA STRUCTURE</td><td>one record per subject per parameter per analysis visit per analysis timepoint</td><td>Analysis</td><td>USUBJID, PARAMCD, AVISIT, ATPT</td><td></td><td><a class="external" href="advs.xpt">advs.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADAE"><td><a href="#IG.IG.ADAE">ADAE</a><span class="standard-refeference">[ADaMIG 1.1]</span></td><td>Adverse Events Analysis Dataset</td><td>OCCURRENCE DATA STRUCTURE<ul class="SubClass"><li class="SubClass">ADVERSE EVENT</li></ul></td><td>one record per subject per adverse event</td><td>Analysis</td><td>USUBJID, AETERM, ASTDT, AESEQ</td><td><p class="linebreakcell">See ADRG Section 5.2.3 ADAE - Adverse Event Analysis Dataset for more details.</p><p class="linebreakcell"><a class="external" href="adrg.pdf">Analysis Data Reviewer's Guide</a><span class="external-link-gif"></span> </p></td><td><a class="external" href="adae.xpt">adae.xpt</a><span class="external-link-gif"></span> </td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADSL"></a><div class="containerbox"><h1 class="invisible">Subject-Level Analysis (ADSL) </h1><table summary="ItemGroup IG.IG.ADSL"><caption><span>ADSL (Subject-Level Analysis) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adsl.xpt">adsl.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: DM.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: DM.USUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: DM.SUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: DM.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.SITEGR1"></a>SITEGR1</td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Refer to SAP, Section 7.1.
If not pooled then SITEGR1=SITEID.
If pooled, SITEGR1 will be 900</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.ARM"></a>ARM</td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.ARM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRT01P"></a>TRT01P</td><td>Planned Treatment for Period 01</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.ARM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRT01PN"></a>TRT01PN</td><td>Planned Treatment for Period 01 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Numeric code for TRT01P which corresponds to the randomized dose</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRT01A"></a>TRT01A</td><td>Actual Treatment for Period 01</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRT01AN"></a>TRT01AN</td><td>Actual Treatment for Period 01 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Numeric code for TRT01A which corresponds to the randomized dose</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRTDURD"></a>TRTDURD</td><td>Total Treatment Duration (Days)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">TRTEDT-TRTSDT+1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AVGDD"></a>AVGDD</td><td>Avg Daily Dose (as planned)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">CUMDOSE/TRTDUR</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.CUMDOSE"></a>CUMDOSE</td><td>Cumulative Dose (as planned)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For ARMN=0 or 1: CUMDOSE=TRT01PN*TRTDUR. ---
For ARMN=2: CUMDOSE will be based on 54mg per day for the # of days subj was in 1st dosing interval (i.e., visit4date-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subj discontinued &lt;=visit 4 and &gt; visit 3), 81mg per day for the # of days subj was in 2nd dosing interval (i.e., visit12date-visit4date if 2nd interval completed, TRTEDT-visit4date if subj discontinued &lt;= visit 12 and &gt; visit 4), and 54mg per day for the # of days subj was in 3rd dosing interval (i.e., TRTEDT - visit12date if subj continued after visit 12).</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: DM.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Character variable derived from ADSL.AGEGR1N</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AGEGR1 = 1 if AGE &lt;65.
AGEGR1 = 2 if AGE 65-80.
AGEGR1 = 3 if AGE &gt;80.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.AGEU"></a>AGEU</td><td>Age Units</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEU">Age Unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"YEARS"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.AGEU</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.RACE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Numeric code for RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.SEX</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.ETHNIC"></a>ETHNIC</td><td>Ethnicity</td><td class="datatype">text</td><td class="number">22</td><td><span class="linebreakcell"><a href="#CL.CL.ETHNIC">Ethnicity</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"NOT HISPANIC OR LATINO"</li><li class="codelist-item">•&nbsp;"HISPANIC OR LATINO"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.ETHNIC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if ITTFL='Y' and TRTSDT ne missing. N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.ITTFL"></a>ITTFL</td><td>Intent-To-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if ARMCD ne ' '. N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.EFFFL"></a>EFFFL</td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM&gt;3 AND at least one record in QS for CIBIC+ with VISITNUM&gt;3.
N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.COMP8FL"></a>COMP8FL</td><td>Completers of Week 8 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if subject has a SV.VISITNUM=8 and ENDDT &gt;= date of visit 8, N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.COMP16FL"></a>COMP16FL</td><td>Completers of Week 16 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if subject has a SV.VISITNUM=10 and ENDDT&gt;=date of visit 10, N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if subject has a SV.VISITNUM=12 and ENDDT&gt;= date of visit 12 , N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DISCONFL"></a>DISCONFL</td><td>Did the Subject Discontinue the Study?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if DCREASCD ^= 'Completed'. Null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.DSRAEFL"></a>DSRAEFL</td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if DCREASCD='Adverse Event'. Null otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DTHFL"></a>DTHFL</td><td>Subject Died?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: DM.DTHFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.BMIBL"></a>BMIBL</td><td>Baseline BMI (kg/m^2)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">WEIGHTBL / ((HEIGHTBL*100)**2)</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.BMIBLGR1"></a>BMIBLGR1</td><td>Pooled Baseline BMI Group 1</td><td class="datatype">text</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.BMICAT">BMI Category</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;25" = "Normal"</li><li class="codelist-item">•&nbsp;"25-&lt;30" = "Overweight"</li><li class="codelist-item">•&nbsp;"&gt;=30" = "Obese"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">BMIBLGR1=Normal if . &lt; BMIBL &lt;25.
BMIBLGR1=Overweight if 25 &lt;=BMIBL &lt;30.
BMIBLGR1=Obese if BMIBL &gt;=30.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.HEIGHTBL"></a>HEIGHTBL</td><td>Baseline Height (cm)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.WEIGHTBL"></a>WEIGHTBL</td><td>Baseline Weight (kg)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.EDUCLVL"></a>EDUCLVL</td><td>Years of Education</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SC.SCSTRESN where SC.SCTESTCD=YEARSEDU</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DISONSDT"></a>DISONSDT</td><td>Date of Onset of Disease</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.DURDIS"></a>DURDIS</td><td>Duration of Disease (Months)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">number of months between VISIT1DT and DISONSET</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DURDSGR1"></a>DURDSGR1</td><td>Pooled Disease Duration Group 1</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.DURDISC">Duration of Disease Category</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;12"</li><li class="codelist-item">•&nbsp;"&gt;=12"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">grouping DURDIS values as &lt;12 and &gt;=12</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.VISIT1DT"></a>VISIT1DT</td><td>Date of Visit 1</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.RFSTDTC"></a>RFSTDTC</td><td>Subject Reference Start Date/Time</td><td class="datatype">datetime</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Predecessor: DM.RFSTDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RFENDTC"></a>RFENDTC</td><td>Subject Reference End Date/Time</td><td class="datatype">datetime</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">Predecessor: DM.RFENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.VISNUMEN"></a>VISNUMEN</td><td>End of Trt Visit (Vis 12 or Early Term.)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RFENDT"></a>RFENDT</td><td>Date of Discontinuation/Completion</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">RFENDTC converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DCDECOD"></a>DCDECOD</td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="number">27</td><td><a href="#CL.CL.DISCCD">Standardized Disposition Term</a><p class="linebreakcell">
                  [9 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">DS.DSDECOD where DSCAT='DISPOSITION EVENT'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.EOSSTT"></a>EOSSTT</td><td>End of Study Status</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">COMPLETED if ADSL.DCDECOD='COMPLETED'. DISCONTINUED if ADSL.DCDECOD not equal to COMPLETED.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DCSREAS"></a>DCSREAS</td><td>Reason for Discontinuation from Study</td><td class="datatype">text</td><td class="number">18</td><td><a href="#CL.CL.DISCREAS">Reason for Discontinuation from Study</a><p class="linebreakcell">
                  [10 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.MMSETOT"></a>MMSETOT</td><td>MMSE Total</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">sum of QS.QSORRES values for the subject</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADADAS"></a><div class="containerbox"><h1 class="invisible">ADAS-Cog Analysis (ADADAS) </h1><table summary="ItemGroup IG.IG.ADADAS"><caption><span>ADADAS (ADAS-Cog Analysis) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adadas.xpt">adadas.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.SITEGR1"></a>SITEGR1</td><td></td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ITTFL"></a>ITTFL</td><td></td><td>Intent-to-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.ITTFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.EFFFL"></a>EFFFL</td><td></td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.EFFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.CL.ADADAS.AVISIT">Analysis Visit (ADADAS)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Baseline"</li><li class="codelist-item">•&nbsp;"Week 8"</li><li class="codelist-item">•&nbsp;"Week 16"</li><li class="codelist-item">•&nbsp;"Week 24"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Derived based on windowing algorithm described in SAP, Section 8.2</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ADADAS.AVISITN">Analysis Visit (N) (ADADAS)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Baseline"</li><li class="codelist-item">•&nbsp;8 = "Week 8"</li><li class="codelist-item">•&nbsp;16 = "Week 16"</li><li class="codelist-item">•&nbsp;24 = "Week 24"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADADAS.VISIT">Visit (ADADAS)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADADAS.VISITNUM">Visit (N) (ADADAS)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT&gt;=TRTSDT. ADY = ADT - TRTSDT, if ADT&lt;TRTSDT.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADQSADAS">PARAM_ADQSADAS</a><p class="linebreakcell">
                  [15 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.QSTEST</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADQSADAS">PARAMCD_ADQSADAS</a><p class="linebreakcell">
                  [15 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.QSTESTCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADQSADAS">PARAMN_ADQSADAS</a><p class="linebreakcell">
                  [15 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADADAS)</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADADAS.IT.ADADAS.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM01" (Word Recall Task)</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM02" (Naming Objects And Fingers (Refer To 5 C)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM03" (Delayed Word Recall)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM04" (Commands)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM05" (Constructional Praxis)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM06" (Ideational Praxis)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM07" (Orientation)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM08" (Word Recognition)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM09" (Attention/Visual Search Task)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM10" (Maze Solution)</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM11" (Spoken Language Ability)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM12" (Comprehension Of Spoken Language)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM13" (Word Finding Difficulty In Spontaneous S)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACITM14" (Recall Of Test Instructions)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADADAS.IT.ADADAS.AVAL"><td></td><td><a href="#IG.ADADAS.IT.ADADAS.PARAMCD" title="Parameter Code">PARAMCD</a> = "ACTOT" (Adas-Cog(11) Subscore)</td><td></td><td class="datatype">float</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see SAP section 14.2 for details on adjusting for missing values.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PCHG"></a>PCHG</td><td></td><td>Percent Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">100* (CHG/BASE), for post baseline records.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: QS.QSBLFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Record Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If multiple visits fall into the same visit window, then the one closest to the target date is chosen for analysis. These are flagged with ANL01FL="Y".</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.DTYPE"></a>DTYPE</td><td></td><td>Derivation Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.DTYPE">Derivation Type</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOCF" = "Last Observation Carried Forward"</li><li class="codelist-item">•&nbsp;"AVERAGE" = "Average"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWRANGE"></a>AWRANGE</td><td></td><td>Analysis Window Valid Relative Range</td><td class="datatype">text</td><td class="number">9</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Window range, specified in the SAP.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWTARGET"></a>AWTARGET</td><td></td><td>Analysis Window Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Target day within the window, specified in the SAP.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWTDIFF"></a>AWTDIFF</td><td></td><td>Analysis Window Diff from Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWLO"></a>AWLO</td><td></td><td>Analysis Window Beginning Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Start day of the window, specified in the SAP.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWHI"></a>AWHI</td><td></td><td>Analysis Window Ending Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">End day of the window, specified in the SAP.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWU"></a>AWU</td><td></td><td>Analysis Window Unit</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.AWU">Analysis Window Unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DAYS" = "DAYS"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Assigned as "DAYS".</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.QSSEQ"></a>QSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSEQ</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADCIBC"></a><div class="containerbox"><h1 class="invisible">CIBIC+ Analysis (ADCIBC) </h1><table summary="ItemGroup IG.IG.ADCIBC"><caption><span>ADCIBC (CIBIC+ Analysis) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adcibc.xpt">adcibc.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.SITEGR1"></a>SITEGR1</td><td></td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: QS.USUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.ITTFL"></a>ITTFL</td><td></td><td>Intent-to-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.ITTFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.EFFFL"></a>EFFFL</td><td></td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.EFFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.CL.ADCIBC.AVISIT">Analysis Visit (ADCIBC)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Week 8"</li><li class="codelist-item">•&nbsp;"Week 16"</li><li class="codelist-item">•&nbsp;"Week 24"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Character version of the visit.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ADCIBC.AVISITN">Analysis Visit (N) (ADCIBC)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;8 = "Week 8"</li><li class="codelist-item">•&nbsp;16 = "Week 16"</li><li class="codelist-item">•&nbsp;24 = "Week 24"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Using window method in SAP Page 10 to determine AVISITN value based on ADY.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADCIBC.VISIT">Visit (ADCIBC)</a><p class="linebreakcell">
                  [10 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADCIBC.VISITNUM">Visit (N) (ADCIBC)</a><p class="linebreakcell">
                  [10 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT&gt;=TRTSDT. ADY = ADT - TRTSDT, if ADT&lt;TRTSDT.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMCD_ADQSCIBC">PARAMCD_ADQSCIBC</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CIBICVAL" = "CIBIC Score"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "CIBICVAL"</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><span class="linebreakcell"><a href="#CL.CL.PARAM_ADQSCIBC">PARAM_ADQSCIBC</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CIBIC Score"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "CIBIC Score"</p></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMN_ADQSCIBC">PARAMN_ADQSCIBC</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "CIBIC Score"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADCIBC)</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADCIBC.IT.ADCIBC.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADCIBC.IT.ADCIBC.AVAL"><td></td><td><a href="#IG.ADCIBC.IT.ADCIBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CIBICVAL" (CIBIC Score)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set ANL01FL=Y based on SAP Page 10 analysis windows.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.DTYPE"></a>DTYPE</td><td></td><td>Derivation Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.DTYPE">Derivation Type</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOCF" = "Last Observation Carried Forward"</li><li class="codelist-item">•&nbsp;"AVERAGE" = "Average"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.AWRANGE"></a>AWRANGE</td><td></td><td>Analysis Window Valid Relative Range</td><td class="datatype">text</td><td class="number">9</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Window range, specified in the SAP.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AWTARGET"></a>AWTARGET</td><td></td><td>Analysis Window Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Target day within the window, specified in the SAP.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.AWTDIFF"></a>AWTDIFF</td><td></td><td>Analysis Window Diff from Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AWLO"></a>AWLO</td><td></td><td>Analysis Window Beginning Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Start day of the window, specified in the SAP.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.AWHI"></a>AWHI</td><td></td><td>Analysis Window Ending Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">End day of the window, specified in the SAP.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADCIBC.IT.ADCIBC.AWU"></a>AWU</td><td></td><td>Analysis Window Unit</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.AWU">Analysis Window Unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DAYS" = "DAYS"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Assigned as "DAYS".</div></td></tr><tr class="tableroweven"><td><a id="IG.ADCIBC.IT.ADCIBC.QSSEQ"></a>QSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSEQ</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBC"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Blood Chemistry (ADLBC) </h1><table summary="ItemGroup IG.IG.ADLBC"><caption><span>ADLBC (Analysis Dataset Lab Blood Chemistry) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adlbc.xpt">adlbc.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: LB.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.DSRAEFL"></a>DSRAEFL</td><td></td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADLBC.AVISIT">Analysis Visit (ADLBC)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBC.AVISITN">Analysis Visit (N) (ADLBC)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADLBC.VISIT">Visit (ADLBC)</a><p class="linebreakcell">
                  [22 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADLBC.VISITNUM">Visit (N) (ADLBC)</a><p class="linebreakcell">
                  [22 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBC">PARAM_ADLBC</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100L same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBC">PARAMCD_ADLBC</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBC">PARAMN_ADLBC</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for Parameter</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.PARCAT1"></a>PARCAT1</td><td></td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEM" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEM" = "Hematology"</li><li class="codelist-item">•&nbsp;"HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to 'CHEM'</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADLBC.IT.ADLBC.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "ALB" (Albumin (g/L))</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "ALP" (Alkaline Phosphatase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "ALT" (Alanine Aminotransferase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "AST" (Aspartate Aminotransferase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "BILI" (Bilirubin (umol/L))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "BUN" (Blood Urea Nitrogen (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CA" (Calcium (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">7</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CHOL" (Cholesterol (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CK" (Creatine Kinase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CL" (Chloride (mmol/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "CREAT" (Creatinine (umol/L))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "GGT" (Gamma Glutamyl Transferase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "GLUC" (Glucose (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "K" (Potassium (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "PHOS" (Phosphate (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">7</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "PROT" (Protein (g/L))</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "SODIUM" (Sodium (mmol/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBC.IT.ADLBC.AVAL"><td></td><td><a href="#IG.ADLBC.IT.ADLBC.PARAMCD" title="Parameter Code">PARAMCD</a> = "URATE" (Urate (umol/L))</td><td></td><td class="datatype">float</td><td class="number">7</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.LBSTRESN when ADLBC.ABLFL=Y</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.A1LO"></a>A1LO</td><td></td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRLO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.A1HI"></a>A1HI</td><td></td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.R2A1LO"></a>R2A1LO</td><td></td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.R2A1HI"></a>R2A1HI</td><td></td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.BR2A1LO"></a>BR2A1LO</td><td></td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.BR2A1HI"></a>BR2A1HI</td><td></td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive, null otherwise; only the first on-treatment AVAL that has absolute val equal to the max is flagged.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.ALBTRVAL"></a>ALBTRVAL</td><td></td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ANRIND"></a>ANRIND</td><td></td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if AVAL &lt; (0.5*LBSTNRLO) then ANRIND='L'.
Else if AVAL &gt; 1.5* LBSTNRHI then ANRIND='H'.
ANRIND='N' otherwise. Used for shift tables</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.BNRIND"></a>BNRIND</td><td></td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.ANRIND when ADLBC.ABLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AENTMTFL"></a>AENTMTFL</td><td></td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Last observed value for this lab parameter during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.LBSEQ"></a>LBSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.LBNRIND"></a>LBNRIND</td><td></td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">Reference Range Indicator</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOW"</li><li class="codelist-item">•&nbsp;"NORMAL"</li><li class="codelist-item">•&nbsp;"HIGH"</li><li class="codelist-item">•&nbsp;"ABNORMAL"</li></ul></td><td><div class="linebreakcell">Predecessor: LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.LBSTRESN"></a>LBSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBCPV"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Blood Chemistry (Previous Visit) (ADLBCPV) </h1><table summary="ItemGroup IG.IG.ADLBCPV"><caption><span>ADLBCPV (Analysis Dataset Lab Blood Chemistry (Previous Visit)) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adlbcpv.xpt">adlbcpv.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: LB.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.DSRAEFL"></a>DSRAEFL</td><td></td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADLBCPV.AVISIT">Analysis Visit (ADLBCPV)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBCPV.AVISITN">Analysis Visit (N) (ADLBCPV)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADLBCPV.VISIT">Visit (ADLBCPV)</a><p class="linebreakcell">
                  [22 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADLBCPV.VISITNUM">Visit (N) (ADLBCPV)</a><p class="linebreakcell">
                  [22 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBCPV">PARAM_ADLBCPV</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBCPV">PARAMCD_ADLBCPV</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBCPV">PARAMN_ADLBCPV</a><p class="linebreakcell">
                  [18 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for Parameter</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.PARCAT1"></a>PARCAT1</td><td></td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEM" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEM" = "Hematology"</li><li class="codelist-item">•&nbsp;"HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to 'CHEM'</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADLBCPV.IT.ADLBCPV.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_ALB" (Albumin (g/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_ALP" (Alkaline Phosphatase (U/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_ALT" (Alanine Aminotransferase (U/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_AST" (Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_BILI" (Bilirubin (umol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_BUN" (Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_CA" (Calcium (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_CHOL" (Cholesterol (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_CK" (Creatine Kinase (U/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_CL" (Chloride (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_CREAT" (Creatinine (umol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_GGT" (Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_GLUC" (Glucose (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_K" (Potassium (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_PHOS" (Phosphate (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_PROT" (Protein (g/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_SODIUM" (Sodium (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBCPV.IT.ADLBCPV.AVAL"><td></td><td><a href="#IG.ADLBCPV.IT.ADLBCPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_URATE" (Urate (umol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBCPV.LBSTRESN when ADLBCPV.ABLFL=Y</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.A1LO"></a>A1LO</td><td></td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRLO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.A1HI"></a>A1HI</td><td></td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.R2A1LO"></a>R2A1LO</td><td></td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.R2A1HI"></a>R2A1HI</td><td></td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.BR2A1LO"></a>BR2A1LO</td><td></td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.BR2A1HI"></a>BR2A1HI</td><td></td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ALBTRVAL"></a>ALBTRVAL</td><td></td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ANRIND"></a>ANRIND</td><td></td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if AVAL &lt; -1 then ANRIND='L'.
If AVAL &gt; 1 then ANRIND='H'.
ANRIND='N' otherwise.
Null if LBBLFL=Y or AVAL=null</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.BNRIND"></a>BNRIND</td><td></td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.ANRIND when ADLBC.ABLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.AENTMTFL"></a>AENTMTFL</td><td></td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Last observed value for this lab parameter during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.LBSEQ"></a>LBSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBCPV.IT.ADLBCPV.LBNRIND"></a>LBNRIND</td><td></td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">Reference Range Indicator</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOW"</li><li class="codelist-item">•&nbsp;"NORMAL"</li><li class="codelist-item">•&nbsp;"HIGH"</li><li class="codelist-item">•&nbsp;"ABNORMAL"</li></ul></td><td><div class="linebreakcell">Predecessor: LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBCPV.IT.ADLBCPV.LBSTRESN"></a>LBSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBH"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Hematology (ADLBH) </h1><table summary="ItemGroup IG.IG.ADLBH"><caption><span>ADLBH (Analysis Dataset Lab Hematology) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adlbh.xpt">adlbh.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: LB.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.DSRAEFL"></a>DSRAEFL</td><td></td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADLBH.AVISIT">Analysis Visit (ADLBH)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBH.AVISITN">Analysis Visit (N) (ADLBH)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADLBH.VISIT">Visit (ADLBH)</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADLBH.VISITNUM">Visit (N) (ADLBH)</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBH">PARAM_ADLBH</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LBTEST concatenated with LBSTRESU.
For PARAMN&gt;100: LBTEST concatenated with LB.LBSTRESU concatenated with "change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBH">PARAMCD_ADLBH</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBH">PARAMN_ADLBH</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for Parameter</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.PARCAT1"></a>PARCAT1</td><td></td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEM" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEM" = "Hematology"</li><li class="codelist-item">•&nbsp;"HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to 'HEM'</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADLBH.IT.ADLBH.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "ANISO" (Anisocytes)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "BASO" (Basophils (GI/L))</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "EOS" (Eosinophils (GI/L))</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "HCT" (Hematocrit)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "HGB" (Hemoglobin (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "LYM" (Lymphocytes (GI/L))</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MACROCY" (Macrocytes)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MCH" (Ery. Mean Corpuscular Hemoglobin (fmol(Fe)))</td><td></td><td class="datatype">float</td><td class="number">7</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MCHC" (Ery. Mean Corpuscular HGB Concentration (mmol/L))</td><td></td><td class="datatype">float</td><td class="number">7</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MCV" (Ery. Mean Corpuscular Volume (fL))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MICROCY" (Microcytes)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "MONO" (Monocytes (GI/L))</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "PLAT" (Platelet (GI/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "POIKILO" (Poikilocytes)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "POLYCHR" (Polychromasia)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "RBC" (Erythrocytes (TI/L))</td><td></td><td class="datatype">float</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBH.IT.ADLBH.AVAL"><td></td><td><a href="#IG.ADLBH.IT.ADLBH.PARAMCD" title="Parameter Code">PARAMCD</a> = "WBC" (Leukocytes (GI/L))</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LBSTRESN when ADLBC.ABLFL=Y</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.A1LO"></a>A1LO</td><td></td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRLO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.A1HI"></a>A1HI</td><td></td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.R2A1LO"></a>R2A1LO</td><td></td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.R2A1HI"></a>R2A1HI</td><td></td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.BR2A1LO"></a>BR2A1LO</td><td></td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.BR2A1HI"></a>BR2A1HI</td><td></td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.ALBTRVAL"></a>ALBTRVAL</td><td></td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ANRIND"></a>ANRIND</td><td></td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If AVAL &lt; (0.5*LBSTNRLO) then ANRIND='L'.
If LAVAL &gt; 1.5* LBSTNRHI then ANRIND='H'. ANRIND='N' otherwise.
Used for shift tables.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.BNRIND"></a>BNRIND</td><td></td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.ANRIND when ADLBC.ABLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AENTMTFL"></a>AENTMTFL</td><td></td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Last observed value for this lab test during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.LBSEQ"></a>LBSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.LBNRIND"></a>LBNRIND</td><td></td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">Reference Range Indicator</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOW"</li><li class="codelist-item">•&nbsp;"NORMAL"</li><li class="codelist-item">•&nbsp;"HIGH"</li><li class="codelist-item">•&nbsp;"ABNORMAL"</li></ul></td><td><div class="linebreakcell">Predecessor: LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.LBSTRESN"></a>LBSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBHPV"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Hematology (Previous Visit) (ADLBHPV) </h1><table summary="ItemGroup IG.IG.ADLBHPV"><caption><span>ADLBHPV (Analysis Dataset Lab Hematology (Previous Visit)) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adlbhpv.xpt">adlbhpv.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: LB.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.DSRAEFL"></a>DSRAEFL</td><td></td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADLBHPV.AVISIT">Analysis Visit (ADLBHPV)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBHPV.AVISITN">Analysis Visit (N) (ADLBHPV)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADLBHPV.VISIT">Visit (ADLBHPV)</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADLBHPV.VISITNUM">Visit (N) (ADLBHPV)</a><p class="linebreakcell">
                  [19 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBHPV">PARAM_ADLBHPV</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBHPV">PARAMCD_ADLBHPV</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBHPV">PARAMN_ADLBHPV</a><p class="linebreakcell">
                  [17 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADLBHPV)</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.PARCAT1"></a>PARCAT1</td><td></td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEM" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEM" = "Hematology"</li><li class="codelist-item">•&nbsp;"HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to 'HEM'</p></td></tr><tr class="tablerowodd"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADLBHPV.IT.ADLBHPV.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_BASO" (Basophils (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_EOS" (Eosinophils (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_HCT" (Hematocrit change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_HGB" (Hemoglobin (mmol/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_LYM" (Lymphocytes (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_MCH" (Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_MCHC" (Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_MCV" (Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_MONO" (Monocytes (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_PLAT" (Platelet (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_RBC" (Erythrocytes (TI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="vlm tablerowodd IG.ADLBHPV.IT.ADLBHPV.AVAL"><td></td><td><a href="#IG.ADLBHPV.IT.ADLBHPV.PARAMCD" title="Parameter Code">PARAMCD</a> = "_WBC" (Leukocytes (GI/L) change from previous visit, relative to normal range)</td><td></td><td class="datatype">float</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBHPV.LBSTRESN when ADLBHPV.ABLFL=Y</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.A1LO"></a>A1LO</td><td></td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRLO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.A1HI"></a>A1HI</td><td></td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTNRLO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.R2A1LO"></a>R2A1LO</td><td></td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.R2A1HI"></a>R2A1HI</td><td></td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.BR2A1LO"></a>BR2A1LO</td><td></td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.BR2A1HI"></a>BR2A1HI</td><td></td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ALBTRVAL"></a>ALBTRVAL</td><td></td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ANRIND"></a>ANRIND</td><td></td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If AVAL &lt; -1 then ANRIND='L'.
If AVAL &gt; 1 then ANRIND='H'.
ANRIND='N' otherwise.
Null if LBBLFL=Y or AVAL=null</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.BNRIND"></a>BNRIND</td><td></td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">Low Normal High</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"L" = "Low"</li><li class="codelist-item">•&nbsp;"N" = "Normal"</li><li class="codelist-item">•&nbsp;"H" = "High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.ANRIND when ADLBC.ABLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.AENTMTFL"></a>AENTMTFL</td><td></td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Last observed value for this lab test during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.LBSEQ"></a>LBSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHPV.IT.ADLBHPV.LBNRIND"></a>LBNRIND</td><td></td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">Reference Range Indicator</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOW"</li><li class="codelist-item">•&nbsp;"NORMAL"</li><li class="codelist-item">•&nbsp;"HIGH"</li><li class="codelist-item">•&nbsp;"ABNORMAL"</li></ul></td><td><div class="linebreakcell">Predecessor: LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHPV.IT.ADLBHPV.LBSTRESN"></a>LBSTRESN</td><td></td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBSTRESN</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBHY"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Hy's Law (ADLBHY) </h1><table summary="ItemGroup IG.IG.ADLBHY"><caption><span>ADLBHY (Analysis Dataset Lab Hy's Law) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adlbhy.xpt">adlbhy.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SUBJID"></a>SUBJID</td><td></td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: LB.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.DSRAEFL"></a>DSRAEFL</td><td></td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADLBHY.AVISIT">Analysis Visit (ADLBHY)</a><p class="linebreakcell">
                  [9 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBHY.AVISITN">Analysis Visit (N) (ADLBHY)</a><p class="linebreakcell">
                  [9 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADLBHY.VISIT">Visit (ADLBHY)</a><p class="linebreakcell">
                  [9 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADLBHY.VISITNUM">Visit (N) (ADLBHY)</a><p class="linebreakcell">
                  [9 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMTYP"></a>PARAMTYP</td><td></td><td>Parameter Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMTYP">PARAMTYP</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DERIVED" = "DERIVED"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "DERIVED"</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBHY">PARAM_ADLBHY</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">same as LBTEST concatenated with LBSTRESU except for hylaw params</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBHY">PARAMCD_ADLBHY</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to appropriate value as needed for HY's Law calculations</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBHY">PARAMN_ADLBHY</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for Parameter</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARCAT1"></a>PARCAT1</td><td></td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">Laboratory Cateogry</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"CHEM" = "Chemistry"</li><li class="codelist-item">•&nbsp;"HEM" = "Hematology"</li><li class="codelist-item">•&nbsp;"HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "HYLAW"</p></td></tr><tr class="tableroweven"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADLBHY.IT.ADLBHY.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "ALT" (Alanine Aminotransferase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.AVAL</div></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "AST" (Aspartate Aminotransferase (U/L))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.AVAL</div></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "BILI" (Bilirubin (umol/L))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.AVAL</div></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "BILIHY" (Bilirubin 1.5 x ULN)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For a given visit, if param='BILI' and r2a1hi &gt; 1.5 then aval=1.
Otherwise if param='BILI' then aval=0</div></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "HYLAW" (Total Bili 1.5 x ULN and Transaminase 1.5 x ULN)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For a given visit, if param='BILHY' or 'TRANSHY' and if both has aval=1 then for this param then aval=1.
Otherwise if for a given visit, if param='BILHY' or 'TRANSHY' then aval=0.</div></td></tr><tr class="vlm tableroweven IG.ADLBHY.IT.ADLBHY.AVAL"><td></td><td><a href="#IG.ADLBHY.IT.ADLBHY.PARAMCD" title="Parameter Code">PARAMCD</a> = "TRANSHY" (Transaminase 1.5 x ULN)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">For a given visit, if param='ALT' or 'AST' and if either r2a1hi &gt; 1.5 then aval=1.
Otherwise if param='ALT' or 'AST' then aval=0</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADLBC.AVAL when ADLBC.ABLFL=Y</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.A1LO"></a>A1LO</td><td></td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.A1LO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.A1HI"></a>A1HI</td><td></td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.A1HI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.R2A1LO"></a>R2A1LO</td><td></td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.R2A1LO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.R2A1HI"></a>R2A1HI</td><td></td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.R2A1HI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.BR2A1LO"></a>BR2A1LO</td><td></td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.BR2A1LO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.BR2A1HI"></a>BR2A1HI</td><td></td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADLBC.BR2A1HI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADLBC.ABLFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.SHIFT1"></a>SHIFT1</td><td></td><td>Shift 1</td><td class="datatype">text</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.CL.SHIFT">Shift</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"High to Normal"</li><li class="codelist-item">•&nbsp;"Normal to Normal"</li><li class="codelist-item">•&nbsp;"Normal to High"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set to "High to Normal" if base=1 and aval=0.
Set to "Normal to Normal" if base=0 and aval=0.
Set to "Normal to High" if base=0 and aval=1.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SHIFT1N"></a>SHIFT1N</td><td></td><td>Shift 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.SHIFTN">Shift (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "High to Normal"</li><li class="codelist-item">•&nbsp;1 = "Normal to Normal"</li><li class="codelist-item">•&nbsp;2 = "Normal to High"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for SHIFT1</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1"></a>CRIT1</td><td></td><td>Analysis Criterion 1</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to 'R2A1HI &gt; 1.5'</p></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1FL"></a>CRIT1FL</td><td></td><td>Criterion 1 Evaluation Result Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If R21AHI &gt; 1.5 then set to 'Y'.
If R2A1HI is not missing then set to 'N'.
Else set to missing.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1FN"></a>CRIT1FN</td><td></td><td>Criterion 1 Evaluation Result Flag (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.YNN">No Yes Response (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "No"</li><li class="codelist-item">•&nbsp;1 = "Yes"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for CRIT1FL</p></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADNPIX"></a><div class="containerbox"><h1 class="invisible">NPI-X Item Analysis Data (ADNPIX) </h1><table summary="ItemGroup IG.IG.ADNPIX"><caption><span>ADNPIX (NPI-X Item Analysis Data) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adnpix.xpt">adnpix.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.SITEGR1"></a>SITEGR1</td><td></td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: QS.USUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.ITTFL"></a>ITTFL</td><td></td><td>Intent-to-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.ITTFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.EFFFL"></a>EFFFL</td><td></td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.EFFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.COMP24FL"></a>COMP24FL</td><td></td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.COMP24FL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADNPIX.AVISIT">Analysis Visit (ADNPIX)</a><p class="linebreakcell">
                  [15 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Character version of the visit.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADNPIX.AVISITN">Analysis Visit (N) (ADNPIX)</a><p class="linebreakcell">
                  [15 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Using window method in SAP Page 10 to determine AVISITN value based on ADY.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT&gt;=TRTSDT. ADY = ADT - TRTSDT, if ADT&lt;TRTSDT.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADNPIX.VISITNUM">Visit (N) (ADNPIX)</a><p class="linebreakcell">
                  [16 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADNPIX.VISIT">Visit (ADNPIX)</a><p class="linebreakcell">
                  [16 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADQSNPIX">PARAM_ADQSNPIX</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.QSTEST</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADQSNPIX">PARAMCD_ADQSNPIX</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: QS.QSTESTCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADQSNPIX">PARAMN_ADQSNPIX</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADNPIX)</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.PARAMTYP"></a>PARAMTYP</td><td></td><td>Parameter Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMTYP">PARAMTYP</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DERIVED" = "DERIVED"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "DERIVED"</p></td></tr><tr class="tableroweven"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADNPIX.IT.ADNPIX.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM01S" (NPI-X Item A (Delusion) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM02S" (NPI-X Item B (Hallucination) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM03S" (NPI-X Item C (Agitation/Agression) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM04S" (NPI-X Item D (Depression/Dysphoria) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM05S" (NPI-X Item E (Anxiety) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM06S" (NPI-X Item F (Eupohoria/Elation) Score)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM07S" (NPI-X Item G (Apathy/Indifference) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM08S" (NPI-X Item H (Disinhibition) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM09S" (NPI-X Item I (Irritability/Lability) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM10S" (NPI-X Item J (Aberrant Motor Behavior) Score)</td><td></td><td class="datatype">integer</td><td class="number">2</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM11S" (NPI-X Item K (Night-time Behavior) Score)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPITM12S" (NPI-X Item L (Appetite/Eating Change) Score)</td><td></td><td class="datatype">integer</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPTOT" (NPI-X (9) Total Score)</td><td></td><td class="datatype">float</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADNPIX.IT.ADNPIX.AVAL"><td></td><td><a href="#IG.ADNPIX.IT.ADNPIX.PARAMCD" title="Parameter Code">PARAMCD</a> = "NPTOTMN" (Mean NPI-X (9) Total (Week 4 to 24))</td><td></td><td class="datatype">float</td><td class="number">13</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">take the mean of AVAL when PARAMCD=NPTOT from week 4 to 24.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.PCHG"></a>PCHG</td><td></td><td>Percent Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">100* (CHG/BASE), for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: QS.QSBLFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Set ANL01FL=Y based on SAP Page 10 analysis windows.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.DTYPE"></a>DTYPE</td><td></td><td>Derivation Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.DTYPE">Derivation Type</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"LOCF" = "Last Observation Carried Forward"</li><li class="codelist-item">•&nbsp;"AVERAGE" = "Average"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "AVERAGE"</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AWRANGE"></a>AWRANGE</td><td></td><td>Analysis Window Valid Relative Range</td><td class="datatype">text</td><td class="number">9</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Window range, specified in the SAP Page 10.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.AWTARGET"></a>AWTARGET</td><td></td><td>Analysis Window Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Target day within the window, specified in the SAP Page 10.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AWTDIFF"></a>AWTDIFF</td><td></td><td>Analysis Window Diff from Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.AWLO"></a>AWLO</td><td></td><td>Analysis Window Beginning Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Start day of the window, specified in the SAP Page 10.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.AWHI"></a>AWHI</td><td></td><td>Analysis Window Ending Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">End day of the window, specified in the SAP Page 10.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADNPIX.IT.ADNPIX.AWU"></a>AWU</td><td></td><td>Analysis Window Unit</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.AWU">Analysis Window Unit</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"DAYS" = "DAYS"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Assigned as "DAYS".</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADNPIX.IT.ADNPIX.QSSEQ"></a>QSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: QS.QSSEQ</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADTTE"></a><div class="containerbox"><h1 class="invisible">AE Time To 1st Derm. Event Analysis (ADTTE) </h1><table summary="ItemGroup IG.IG.ADTTE"><caption><span>ADTTE (AE Time To 1st Derm. Event Analysis) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adtte.xpt">adtte.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTDUR"></a>TRTDUR</td><td></td><td>Duration of treatment (days)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTDURD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><span class="linebreakcell"><a href="#CL.CL.PARAM_ADTTE">PARAM_ADTTE</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Time to First Dermatologic Event"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to "Time to First Dermatologic Event"</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMCD_ADTTE">PARAMCD_ADTTE</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"TTDE" = "Time to Derm. Event or End of Study"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Set to" TTDE"</p></td></tr><tr class="tableroweven"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADTTE.IT.ADTTE.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tableroweven IG.ADTTE.IT.ADTTE.AVAL"><td></td><td><a href="#IG.ADTTE.IT.ADTTE.PARAMCD" title="Parameter Code">PARAMCD</a> = "TTDE" (Time to Derm. Event or End of Study)</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADT-STARTDT+1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.STARTDT"></a>STARTDT</td><td></td><td>Time to Event Origin Date for Subject</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADTTE.STARTDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if ADAE.ASTDT is not missing and occurred after TRTSDT then ADAE.ASTDT else convert ADSL.RFENDTC to a SAS numeric date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.CNSR"></a>CNSR</td><td></td><td>Censor</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.CENSOR">Censor</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Event"</li><li class="codelist-item">•&nbsp;1 = "Censored"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if ADAE.TRTEMFL ="Y" then CNSR=0, else CNSR=1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.EVNTDESC"></a>EVNTDESC</td><td></td><td>Event or Censoring Description</td><td class="datatype">text</td><td class="number">25</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">if ADTTE.CNSR = 0 then "Dematologic Event Occured", else if ADTTE.CNSR =1 then "Study Completion Date"</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SRCDOM"></a>SRCDOM</td><td></td><td>Source Domain</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The Source domain referred to in order to populate ADT (either ADAE or ADSL)</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SRCVAR"></a>SRCVAR</td><td></td><td>Source Variable</td><td class="datatype">text</td><td class="number">6</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The Source variable referred to in order to populate ADT (either ASTDT or RFENDT)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SRCSEQ"></a>SRCSEQ</td><td></td><td>Source Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">The value of ADAE.AESEQ if SRCDOM=ADAE, otherwise null.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADVS"></a><div class="containerbox"><h1 class="invisible">Vital Signs Analysis Dataset (ADVS) </h1><table summary="ItemGroup IG.IG.ADVS"><caption><span>ADVS (Vital Signs Analysis Dataset) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="advs.xpt">advs.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.SITEID"></a>SITEID</td><td></td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.USUBJID"></a>USUBJID</td><td></td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: VS.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AGE"></a>AGE</td><td></td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.AGEGR1"></a>AGEGR1</td><td></td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AGEGR1N"></a>AGEGR1N</td><td></td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.RACE"></a>RACE</td><td></td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.RACEN"></a>RACEN</td><td></td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.SEX"></a>SEX</td><td></td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.SAFFL"></a>SAFFL</td><td></td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTSDT"></a>TRTSDT</td><td></td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTEDT"></a>TRTEDT</td><td></td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTP"></a>TRTP</td><td></td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTPN"></a>TRTPN</td><td></td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01PN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTA"></a>TRTA</td><td></td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTAN"></a>TRTAN</td><td></td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.PARAMCD"></a>PARAMCD</td><td></td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADVS">PARAMCD_ADVS</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: VS.VSTESTCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.PARAM"></a>PARAM</td><td></td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADVS">PARAM_ADVS</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: VS.VSTEST</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.PARAMN"></a>PARAMN</td><td></td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADVS">PARAMN_ADVS</a><p class="linebreakcell">
                  [6 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for Parameter</p></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ADT"></a>ADT</td><td></td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">the date part of VS.VSDTC converted to a SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ADY"></a>ADY</td><td></td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ATPTN"></a>ATPTN</td><td></td><td>Analysis Timepoint (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ADVS.ATPTN">Analysis Timepoint (N) (ADVS)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;815 = "AFTER LYING DOWN FOR 5 MINUTES"</li><li class="codelist-item">•&nbsp;816 = "AFTER STANDING FOR 1 MINUTE"</li><li class="codelist-item">•&nbsp;817 = "AFTER STANDING FOR 3 MINUTES"</li></ul></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for ATPT</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ATPT"></a>ATPT</td><td></td><td>Analysis Timepoint</td><td class="datatype">text</td><td class="number">30</td><td><span class="linebreakcell"><a href="#CL.CL.ADVS.ATPT">Analysis Timepoint (ADVS)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"AFTER LYING DOWN FOR 5 MINUTES"</li><li class="codelist-item">•&nbsp;"AFTER STANDING FOR 1 MINUTE"</li><li class="codelist-item">•&nbsp;"AFTER STANDING FOR 3 MINUTES"</li></ul></td><td><div class="linebreakcell">Predecessor: VS.VSTPT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AVISIT"></a>AVISIT</td><td></td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.ADVS.AVISIT">Analysis Visit (ADVS)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Derived from VS.VISIT for values to be included in a per visit analysis. AVISIT is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL", which are not included in a per visit analysis.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.AVISITN"></a>AVISITN</td><td></td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.ADVS.AVISITN">Analysis Visit (N) (ADVS)</a><p class="linebreakcell">
                  [11 Terms]
                </p></td><td><div class="linebreakcell">Assigned (<span class="linebreakcell">Source: Sponsor</span>)</div><p class="linebreakcell">Numeric code for AVISIT</p></td></tr><tr class="tableroweven"><td>AVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.ADVS.IT.ADVS.AVAL">VLM</a></span></td><td></td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><p class="linebreakcell">See parameter level metadata</p></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "DIABP" (Diastolic Blood Pressure (mmHg))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "HEIGHT" (Height (cm))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "PULSE" (Pulse Rate (beats/min))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "SYSBP" (Systolic Blood Pressure (mmHg))</td><td></td><td class="datatype">integer</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "TEMP" (Temperature (C))</td><td></td><td class="datatype">float</td><td class="number">5</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="vlm tableroweven IG.ADVS.IT.ADVS.AVAL"><td></td><td><a href="#IG.ADVS.IT.ADVS.PARAMCD" title="Parameter Code">PARAMCD</a> = "WEIGHT" (Weight (kg))</td><td></td><td class="datatype">float</td><td class="number">6</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSTRESN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.BASE"></a>BASE</td><td></td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">VS.VSSTRESN where VSBLFL="Y"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.BASETYPE"></a>BASETYPE</td><td></td><td>Baseline Type</td><td class="datatype">text</td><td class="number">30</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSTPT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.CHG"></a>CHG</td><td></td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.PCHG"></a>PCHG</td><td></td><td>Percent Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">100* (CHG/BASE), for post baseline records.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.VISITNUM"></a>VISITNUM</td><td></td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.ADVS.VISITNUM">Visit (N) (ADVS)</a><p class="linebreakcell">
                  [16 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: VS.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.VISIT"></a>VISIT</td><td></td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.ADVS.VISIT">Visit (ADVS)</a><p class="linebreakcell">
                  [16 Terms]
                </p></td><td><div class="linebreakcell">Predecessor: VS.VISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.VSSEQ"></a>VSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: VS.VSSEQ</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ANL01FL"></a>ANL01FL</td><td></td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ANL01FL="Y" if the value is to be included in a per visit analysis. ANL01FL is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL"</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ABLFL"></a>ABLFL</td><td></td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: VS.VSBLFL</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADAE"></a><div class="containerbox"><h1 class="invisible">Adverse Events Analysis Dataset (ADAE) </h1><table summary="ItemGroup IG.IG.ADAE"><caption><span>ADAE (Adverse Events Analysis Dataset) -  <span class="standard-refeference">[ADaMIG 1.1]</span><span class="dataset">Location: <a class="external" href="adae.xpt">adae.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Predecessor: AE.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">Planned Arm</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Placebo"</li><li class="codelist-item">•&nbsp;"Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;"Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">Planned Arm (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;0 = "Placebo"</li><li class="codelist-item">•&nbsp;54 = "Xanomeline Low Dose"</li><li class="codelist-item">•&nbsp;81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">Age Group 1</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"&lt;65"</li><li class="codelist-item">•&nbsp;"65-80"</li><li class="codelist-item">•&nbsp;"&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">Age Group 1 (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "&lt;65"</li><li class="codelist-item">•&nbsp;2 = "65-80"</li><li class="codelist-item">•&nbsp;3 = "&gt;80"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">Race</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"ASIAN"</li><li class="codelist-item">•&nbsp;"WHITE"</li><li class="codelist-item">•&nbsp;"BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;"AMERICAN INDIAN OR ALASKA NATIVE"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">Race (N)</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;1 = "WHITE"</li><li class="codelist-item">•&nbsp;2 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">•&nbsp;6 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">•&nbsp;7 = "ASIAN"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"F" = "Female"</li><li class="codelist-item">•&nbsp;"M" = "Male"</li><li class="codelist-item">•&nbsp;"U" = "U; UNK; Unknown"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Predecessor: ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ASTDT"></a>ASTDT</td><td>Analysis Start Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.ASTDTF"></a>ASTDTF</td><td>Analysis Start Date Imputation Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.DATEFL">Date Imputation Flag</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"D" = "Day imputed"</li><li class="codelist-item">•&nbsp;"M" = "Day and Month imputed"</li><li class="codelist-item">•&nbsp;"Y" = "Date (Day, Month and Year) imputed"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ASTDY"></a>ASTDY</td><td>Analysis Start Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">IF ASTDT&gt;=TRTSDT&gt;MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT&gt;ASTDT&gt;MISSING then ASTDY=ASTDT-TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AENDT"></a>AENDT</td><td>Analysis End Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">AE.AEENDTC, converted to a numeric SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AENDY"></a>AENDY</td><td>Analysis End Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">IF AENDT&gt;=TRTSDT&gt;MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT&gt;AENDT&gt;MISSING then AENDY=AENDT-TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.ADURN"></a>ADURN</td><td>AE Duration (N)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">ADURN=AENDT-ASTDT+1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ADURU"></a>ADURU</td><td>AE Duration Units</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If ADURN is not missing then ADURU='DAY'</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AETERM"></a>AETERM</td><td>Reported Term for the Adverse Event</td><td class="datatype">text</td><td class="number">46</td><td></td><td><div class="linebreakcell">Predecessor: AE.AETERM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AELLT"></a>AELLT</td><td>Lowest Level Term</td><td class="datatype">text</td><td class="number">46</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AELLT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AELLTCD"></a>AELLTCD</td><td>Lowest Level Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AELLTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEDECOD"></a>AEDECOD</td><td>Dictionary-Derived Term</td><td class="datatype">text</td><td class="number">46</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AEDECOD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEPTCD"></a>AEPTCD</td><td>Preferred Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AEPTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEHLT"></a>AEHLT</td><td>High Level Term</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AEHLT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEHLTCD"></a>AEHLTCD</td><td>High Level Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AEHLTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEHLGT"></a>AEHLGT</td><td>High Level Group Term</td><td class="datatype">text</td><td class="number">9</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AEHLGT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEHLGTCD"></a>AEHLGTCD</td><td>High Level Group Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AEHLGTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEBODSYS"></a>AEBODSYS</td><td>Body System or Organ Class</td><td class="datatype">text</td><td class="number">67</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AEBODSYS</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESOC"></a>AESOC</td><td>Primary System Organ Class</td><td class="datatype">text</td><td class="number">67</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Predecessor: AE.AESOC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESOCCD"></a>AESOCCD</td><td>Primary System Organ Class Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AESOCCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESEV"></a>AESEV</td><td>Severity/Intensity</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AESEV">Severity/Intensity Scale for Adverse Events</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"MILD" = "1; Grade 1"</li><li class="codelist-item">•&nbsp;"MODERATE" = "2; Grade 2"</li><li class="codelist-item">•&nbsp;"SEVERE" = "3; Grade 3"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESEV</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESER"></a>AESER</td><td>Serious Event</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESER</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESCAN"></a>AESCAN</td><td>Involves Cancer</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESCAN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESCONG"></a>AESCONG</td><td>Congenital Anomaly or Birth Defect</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESCONG</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESDISAB"></a>AESDISAB</td><td>Persist or Signif Disability/Incapacity</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESDISAB</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESDTH"></a>AESDTH</td><td>Results in Death</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESDTH</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESHOSP"></a>AESHOSP</td><td>Requires or Prolongs Hospitalization</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESHOSP</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESLIFE"></a>AESLIFE</td><td>Is Life Threatening</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESLIFE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESOD"></a>AESOD</td><td>Occurred with Overdose</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"N" = "No"</li><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AESOD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEREL"></a>AEREL</td><td>Causality</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AECAUS">Causality</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"NONE"</li><li class="codelist-item">•&nbsp;"POSSIBLE"</li><li class="codelist-item">•&nbsp;"PROBABLE"</li><li class="codelist-item">•&nbsp;"REMOTE"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AEREL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEACN"></a>AEACN</td><td>Action Taken with Study Treatment</td><td class="datatype">text</td><td class="number">1</td><td></td><td><div class="linebreakcell">Predecessor: AE.AEACN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEOUT"></a>AEOUT</td><td>Outcome of Adverse Event</td><td class="datatype">text</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.CL.OUT">Outcome</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"RECOVERED/RESOLVED" = "RECOVERED/RESOLVED"</li><li class="codelist-item">•&nbsp;"NOT RECOVERED/NOT RESOLVED" = "NOT RECOVERED/NOT RESOLVED"</li><li class="codelist-item">•&nbsp;"FATAL" = "FATAL"</li></ul></td><td><div class="linebreakcell">Predecessor: AE.AEOUT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESEQ"></a>AESEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Predecessor: AE.AESEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTEMFL"></a>TRTEMFL</td><td>Treatment Emergent Analysis Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If ASTDT &gt;= TRTSDT &gt; . then TRTEMFL='Y'. Otherwise TRTEMFL='N'</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCCFL"></a>AOCCFL</td><td>1st Occurrence of Any AE Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=?Y?) within each Subject</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCCSFL"></a>AOCCSFL</td><td>1st Occurrence of SOC Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=?Y?) within each Subject and SOC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCCPFL"></a>AOCCPFL</td><td>1st Occurrence of Preferred Term Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC02FL"></a>AOCC02FL</td><td>1st Occurrence 02 Flag for Serious</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=?Y?) within each Subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCC03FL"></a>AOCC03FL</td><td>1st Occurrence 03 Flag for Serious SOC</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=?Y?) within each Subject and SOC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC04FL"></a>AOCC04FL</td><td>1st Occurrence 04 Flag for Serious PT</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.CQ01NAM"></a>CQ01NAM</td><td>Customized Query 01 Name</td><td class="datatype">text</td><td class="number">19</td><td></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC01FL"></a>AOCC01FL</td><td>1st Occurrence 01 Flag for CQ01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y Only</a></span><ul class="codelist"><li class="codelist-item">•&nbsp;"Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived (<span class="linebreakcell">Source: Sponsor</span>)</div><div class="method-code">Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=?Y?) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="decodelist"></a><div class="containerbox"><h1 class="header">CodeLists</h1><div class="codelist" id="CL.CL.ADADAS.AVISIT"><div class="codelist-caption">Analysis Visit (ADADAS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADADAS)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 8</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADADAS.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADADAS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADADAS)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>24</td><td class="codelist-item-decode">Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADADAS.VISIT"><div class="codelist-caption">Visit (ADADAS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADADAS)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>BASELINE</td></tr><tr class="tableroweven"><td>WEEK 2</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>WEEK 8</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>WEEK 16</td></tr><tr class="tablerowodd"><td>WEEK 20</td></tr><tr class="tableroweven"><td>WEEK 24</td></tr><tr class="tablerowodd"><td>RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADADAS.VISITNUM"><div class="codelist-caption">Visit (N) (ADADAS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADADAS)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">BASELINE</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tablerowodd"><td>201</td><td class="codelist-item-decode">RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADCIBC.AVISIT"><div class="codelist-caption">Analysis Visit (ADCIBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADCIBC)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 16</td></tr><tr class="tablerowodd"><td>Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADCIBC.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADCIBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADCIBC)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADCIBC.VISIT"><div class="codelist-caption">Visit (ADCIBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADCIBC)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>WEEK 2</td></tr><tr class="tableroweven"><td>WEEK 4</td></tr><tr class="tablerowodd"><td>AMBUL ECG REMOVAL</td></tr><tr class="tableroweven"><td>WEEK 6</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>WEEK 12</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr><tr class="tableroweven"><td>RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADCIBC.VISITNUM"><div class="codelist-caption">Visit (N) (ADCIBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADCIBC)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tablerowodd"><td>6</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tableroweven"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>201</td><td class="codelist-item-decode">RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADLBC.AVISIT"><div class="codelist-caption">Analysis Visit (ADLBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADLBC)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBC.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADLBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADLBC)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBC.VISIT"><div class="codelist-caption">Visit (ADLBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADLBC)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>WEEK 2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>WEEK 4</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 6.1</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr><tr class="tableroweven"><td>UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr><tr class="tableroweven"><td>UNSCHEDULED 13.1</td></tr></table></div><div class="codelist" id="CL.CL.ADLBC.VISITNUM"><div class="codelist-caption">Visit (N) (ADLBC)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADLBC)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>4.2</td><td class="codelist-item-decode">UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tablerowodd"><td>5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>6.1</td><td class="codelist-item-decode">UNSCHEDULED 6.1</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>13.1</td><td class="codelist-item-decode">UNSCHEDULED 13.1</td></tr></table></div><div class="codelist" id="CL.CL.ADLBCAT"><div class="codelist-caption">Laboratory Cateogry<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Laboratory Cateogry"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CHEM</td><td class="codelist-item-decode">Chemistry</td></tr><tr class="tableroweven"><td>HEM</td><td class="codelist-item-decode">Hematology</td></tr><tr class="tablerowodd"><td>HYLAW</td><td class="codelist-item-decode">Hy's Law</td></tr></table></div><div class="codelist" id="CL.CL.ADLBCPV.AVISIT"><div class="codelist-caption">Analysis Visit (ADLBCPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADLBCPV)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBCPV.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADLBCPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADLBCPV)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBCPV.VISIT"><div class="codelist-caption">Visit (ADLBCPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADLBCPV)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>WEEK 2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>WEEK 4</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 6.1</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr><tr class="tableroweven"><td>UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr><tr class="tableroweven"><td>UNSCHEDULED 13.1</td></tr></table></div><div class="codelist" id="CL.CL.ADLBCPV.VISITNUM"><div class="codelist-caption">Visit (N) (ADLBCPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADLBCPV)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>4.2</td><td class="codelist-item-decode">UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tablerowodd"><td>5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>6.1</td><td class="codelist-item-decode">UNSCHEDULED 6.1</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>13.1</td><td class="codelist-item-decode">UNSCHEDULED 13.1</td></tr></table></div><div class="codelist" id="CL.CL.ADLBH.AVISIT"><div class="codelist-caption">Analysis Visit (ADLBH)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADLBH)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBH.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADLBH)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADLBH)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBH.VISIT"><div class="codelist-caption">Visit (ADLBH)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADLBH)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>WEEK 2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>UNSCHEDULED 5.1</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr><tr class="tableroweven"><td>UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr></table></div><div class="codelist" id="CL.CL.ADLBH.VISITNUM"><div class="codelist-caption">Visit (N) (ADLBH)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADLBH)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHPV.AVISIT"><div class="codelist-caption">Analysis Visit (ADLBHPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADLBHPV)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHPV.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADLBHPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADLBHPV)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHPV.VISIT"><div class="codelist-caption">Visit (ADLBHPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADLBHPV)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>WEEK 2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>UNSCHEDULED 5.1</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr><tr class="tableroweven"><td>UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHPV.VISITNUM"><div class="codelist-caption">Visit (N) (ADLBHPV)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADLBHPV)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHY.AVISIT"><div class="codelist-caption">Analysis Visit (ADLBHY)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADLBHY)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHY.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADLBHY)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADLBHY)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHY.VISIT"><div class="codelist-caption">Visit (ADLBHY)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADLBHY)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>WEEK 2</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>WEEK 6</td></tr><tr class="tablerowodd"><td>WEEK 8</td></tr><tr class="tableroweven"><td>WEEK 12</td></tr><tr class="tablerowodd"><td>WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 24</td></tr></table></div><div class="codelist" id="CL.CL.ADLBHY.VISITNUM"><div class="codelist-caption">Visit (N) (ADLBHY)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADLBHY)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tableroweven"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr></table></div><div class="codelist" id="CL.CL.ADNPIX.AVISIT"><div class="codelist-caption">Analysis Visit (ADNPIX)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADNPIX)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 10</td></tr><tr class="tablerowodd"><td>Week 12</td></tr><tr class="tableroweven"><td>Week 14</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 18</td></tr><tr class="tablerowodd"><td>Week 20</td></tr><tr class="tableroweven"><td>Week 22</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>Weeks 4-24</td></tr></table></div><div class="codelist" id="CL.CL.ADNPIX.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADNPIX)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADNPIX)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">Week 10</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Week 14</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>18</td><td class="codelist-item-decode">Week 18</td></tr><tr class="tablerowodd"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tableroweven"><td>22</td><td class="codelist-item-decode">Week 22</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>98</td><td class="codelist-item-decode">Weeks 4-24</td></tr></table></div><div class="codelist" id="CL.CL.ADNPIX.VISIT"><div class="codelist-caption">Visit (ADNPIX)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADNPIX)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>BASELINE</td></tr><tr class="tableroweven"><td>WEEK 2</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>WEEK 8</td></tr><tr class="tablerowodd"><td>WEEK 10 (T)</td></tr><tr class="tableroweven"><td>WEEK 12</td></tr><tr class="tablerowodd"><td>WEEK 14 (T)</td></tr><tr class="tableroweven"><td>WEEK 16</td></tr><tr class="tablerowodd"><td>WEEK 18 (T)</td></tr><tr class="tableroweven"><td>WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 22 (T)</td></tr><tr class="tableroweven"><td>WEEK 24</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr><tr class="tableroweven"><td>RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADNPIX.VISITNUM"><div class="codelist-caption">Visit (N) (ADNPIX)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADNPIX)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">BASELINE</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tablerowodd"><td>8.1</td><td class="codelist-item-decode">WEEK 10 (T)</td></tr><tr class="tableroweven"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tablerowodd"><td>9.1</td><td class="codelist-item-decode">WEEK 14 (T)</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tablerowodd"><td>10.1</td><td class="codelist-item-decode">WEEK 18 (T)</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>11.1</td><td class="codelist-item-decode">WEEK 22 (T)</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>201</td><td class="codelist-item-decode">RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.ATPT"><div class="codelist-caption">Analysis Timepoint (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Timepoint (ADVS)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>AFTER LYING DOWN FOR 5 MINUTES</td></tr><tr class="tableroweven"><td>AFTER STANDING FOR 1 MINUTE</td></tr><tr class="tablerowodd"><td>AFTER STANDING FOR 3 MINUTES</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.ATPTN"><div class="codelist-caption">Analysis Timepoint (N) (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Timepoint (N) (ADVS)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>815</td><td class="codelist-item-decode">AFTER LYING DOWN FOR 5 MINUTES</td></tr><tr class="tableroweven"><td>816</td><td class="codelist-item-decode">AFTER STANDING FOR 1 MINUTE</td></tr><tr class="tablerowodd"><td>817</td><td class="codelist-item-decode">AFTER STANDING FOR 3 MINUTES</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.AVISIT"><div class="codelist-caption">Analysis Visit (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Analysis Visit (ADVS)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Baseline</td></tr><tr class="tableroweven"><td>Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td></tr><tr class="tableroweven"><td>Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td></tr><tr class="tableroweven"><td>Week 12</td></tr><tr class="tablerowodd"><td>Week 16</td></tr><tr class="tableroweven"><td>Week 20</td></tr><tr class="tablerowodd"><td>Week 24</td></tr><tr class="tableroweven"><td>Week 26</td></tr><tr class="tablerowodd"><td>End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.AVISITN"><div class="codelist-caption">Analysis Visit (N) (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Visit (N) (ADVS)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.VISIT"><div class="codelist-caption">Visit (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Visit (ADVS)"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td></tr><tr class="tableroweven"><td>SCREENING 2</td></tr><tr class="tablerowodd"><td>BASELINE</td></tr><tr class="tableroweven"><td>UNSCHEDULED 3.1</td></tr><tr class="tablerowodd"><td>AMBUL ECG PLACEMENT</td></tr><tr class="tableroweven"><td>WEEK 2</td></tr><tr class="tablerowodd"><td>WEEK 4</td></tr><tr class="tableroweven"><td>AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>WEEK 6</td></tr><tr class="tableroweven"><td>WEEK 8</td></tr><tr class="tablerowodd"><td>WEEK 12</td></tr><tr class="tableroweven"><td>WEEK 16</td></tr><tr class="tablerowodd"><td>WEEK 20</td></tr><tr class="tableroweven"><td>WEEK 24</td></tr><tr class="tablerowodd"><td>WEEK 26</td></tr><tr class="tableroweven"><td>RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.ADVS.VISITNUM"><div class="codelist-caption">Visit (N) (ADVS)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Visit (N) (ADVS)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">SCREENING 2</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">BASELINE</td></tr><tr class="tableroweven"><td>3.1</td><td class="codelist-item-decode">UNSCHEDULED 3.1</td></tr><tr class="tablerowodd"><td>3.5</td><td class="codelist-item-decode">AMBUL ECG PLACEMENT</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>201</td><td class="codelist-item-decode">RETRIEVAL</td></tr></table></div><div class="codelist" id="CL.CL.AECAUS"><div class="codelist-caption">Causality<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Causality"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>NONE</td></tr><tr class="tableroweven"><td>POSSIBLE</td></tr><tr class="tablerowodd"><td>PROBABLE</td></tr><tr class="tableroweven"><td>REMOTE</td></tr></table></div><div class="codelist" id="CL.CL.AESEV"><div class="codelist-caption">Severity/Intensity Scale for Adverse Events [<span class="nci">C66769</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Severity/Intensity Scale for Adverse Events"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>MILD [<span class="nci">C70666</span>]</td><td class="codelist-item-decode">1; Grade 1</td></tr><tr class="tableroweven"><td>MODERATE [<span class="nci">C61376</span>]</td><td class="codelist-item-decode">2; Grade 2</td></tr><tr class="tablerowodd"><td>SEVERE [<span class="nci">C41340</span>]</td><td class="codelist-item-decode">3; Grade 3</td></tr></table></div><div class="codelist" id="CL.CL.AGEGR1"><div class="codelist-caption">Age Group 1<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Age Group 1"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>&lt;65</td></tr><tr class="tableroweven"><td>65-80</td></tr><tr class="tablerowodd"><td>&gt;80</td></tr></table></div><div class="codelist" id="CL.CL.AGEGR1N"><div class="codelist-caption">Age Group 1 (N)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Age Group 1 (N)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">&lt;65</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">65-80</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">&gt;80</td></tr></table></div><div class="codelist" id="CL.CL.AGEU"><div class="codelist-caption">Age Unit [<span class="nci">C66781</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Age Unit"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>YEARS [<span class="nci">C29848</span>]</td></tr></table></div><div class="codelist" id="CL.CL.ARM"><div class="codelist-caption">Planned Arm<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Planned Arm"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Placebo</td></tr><tr class="tableroweven"><td>Xanomeline Low Dose</td></tr><tr class="tablerowodd"><td>Xanomeline High Dose</td></tr></table></div><div class="codelist" id="CL.CL.ARMN"><div class="codelist-caption">Planned Arm (N)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Planned Arm (N)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>54</td><td class="codelist-item-decode">Xanomeline Low Dose</td></tr><tr class="tablerowodd"><td>81</td><td class="codelist-item-decode">Xanomeline High Dose</td></tr></table></div><div class="codelist" id="CL.CL.AWU"><div class="codelist-caption">Analysis Window Unit<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Analysis Window Unit"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DAYS</td><td class="codelist-item-decode">DAYS</td></tr></table></div><div class="codelist" id="CL.CL.BMICAT"><div class="codelist-caption">BMI Category<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - BMI Category"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>&lt;25</td><td class="codelist-item-decode">Normal</td></tr><tr class="tableroweven"><td>25-&lt;30</td><td class="codelist-item-decode">Overweight</td></tr><tr class="tablerowodd"><td>&gt;=30</td><td class="codelist-item-decode">Obese</td></tr></table></div><div class="codelist" id="CL.CL.CENSOR"><div class="codelist-caption">Censor<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Censor"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Event</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Censored</td></tr></table></div><div class="codelist" id="CL.CL.DATEFL"><div class="codelist-caption">Date Imputation Flag [<span class="nci">C81223</span>]<span class="standard-refeference">[CDISC/NCI ADaM 2020-12-18]</span></div><table summary="Controlled Term - Date Imputation Flag"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>D [<span class="nci">C81212</span>]</td><td class="codelist-item-decode">Day imputed</td></tr><tr class="tableroweven"><td>M [<span class="nci">C81211</span>]</td><td class="codelist-item-decode">Day and Month imputed</td></tr><tr class="tablerowodd"><td>Y [<span class="nci">C81210</span>]</td><td class="codelist-item-decode">Date (Day, Month and Year) imputed</td></tr></table></div><div class="codelist" id="CL.CL.DISCCD"><div class="codelist-caption">Standardized Disposition Term<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Standardized Disposition Term"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>COMPLETED</td></tr><tr class="tableroweven"><td>ADVERSE EVENT</td></tr><tr class="tablerowodd"><td>DEATH</td></tr><tr class="tableroweven"><td>LACK OF EFFICACY</td></tr><tr class="tablerowodd"><td>LOST TO FOLLOW-UP</td></tr><tr class="tableroweven"><td>WITHDRAWAL BY SUBJECT</td></tr><tr class="tablerowodd"><td>STUDY TERMINATED BY SPONSOR</td></tr><tr class="tableroweven"><td>PHYSICIAN DECISION</td></tr><tr class="tablerowodd"><td>PROTOCOL VIOLATION</td></tr></table></div><div class="codelist" id="CL.CL.DISCREAS"><div class="codelist-caption">Reason for Discontinuation from Study<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Reason for Discontinuation from Study"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Completed</td></tr><tr class="tableroweven"><td>Adverse Event</td></tr><tr class="tablerowodd"><td>Death</td></tr><tr class="tableroweven"><td>I/E Not Met</td></tr><tr class="tablerowodd"><td>Lack of Efficacy</td></tr><tr class="tableroweven"><td>Lost to Follow-up</td></tr><tr class="tablerowodd"><td>Physician Decision</td></tr><tr class="tableroweven"><td>Protocol Violation</td></tr><tr class="tablerowodd"><td>Sponsor Decision</td></tr><tr class="tableroweven"><td>Withdrew Consent</td></tr></table></div><div class="codelist" id="CL.CL.DTYPE"><div class="codelist-caption">Derivation Type [<span class="nci">C81224</span>]<span class="standard-refeference">[CDISC/NCI ADaM 2020-12-18]</span></div><table summary="Controlled Term - Derivation Type"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LOCF [<span class="nci">C81198</span>]</td><td class="codelist-item-decode">Last Observation Carried Forward</td></tr><tr class="tableroweven"><td>AVERAGE [<span class="nci">C81209</span>]</td><td class="codelist-item-decode">Average</td></tr></table></div><div class="codelist" id="CL.CL.DURDISC"><div class="codelist-caption">Duration of Disease Category<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Duration of Disease Category"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>&lt;12</td></tr><tr class="tableroweven"><td>&gt;=12</td></tr></table></div><div class="codelist" id="CL.CL.ETHNIC"><div class="codelist-caption">Ethnicity<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Ethnicity"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>NOT HISPANIC OR LATINO</td></tr><tr class="tableroweven"><td>HISPANIC OR LATINO</td></tr></table></div><div class="codelist" id="CL.CL.LBNRIND"><div class="codelist-caption">Reference Range Indicator<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Reference Range Indicator"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>LOW</td></tr><tr class="tableroweven"><td>NORMAL</td></tr><tr class="tablerowodd"><td>HIGH</td></tr><tr class="tableroweven"><td>ABNORMAL</td></tr></table></div><div class="codelist" id="CL.CL.LNH"><div class="codelist-caption">Low Normal High<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Low Normal High"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>L</td><td class="codelist-item-decode">Low</td></tr><tr class="tableroweven"><td>N</td><td class="codelist-item-decode">Normal</td></tr><tr class="tablerowodd"><td>H</td><td class="codelist-item-decode">High</td></tr></table></div><div class="codelist" id="CL.CL.OUT"><div class="codelist-caption">Outcome<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Outcome"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>RECOVERED/RESOLVED</td><td class="codelist-item-decode">RECOVERED/RESOLVED</td></tr><tr class="tableroweven"><td>NOT RECOVERED/NOT RESOLVED</td><td class="codelist-item-decode">NOT RECOVERED/NOT RESOLVED</td></tr><tr class="tablerowodd"><td>FATAL</td><td class="codelist-item-decode">FATAL</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADLBC"><div class="codelist-caption">PARAM_ADLBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADLBC"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Albumin (g/L)</td></tr><tr class="tableroweven"><td>Alkaline Phosphatase (U/L)</td></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tablerowodd"><td>Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>Cholesterol (mmol/L)</td></tr><tr class="tablerowodd"><td>Creatine Kinase (U/L)</td></tr><tr class="tableroweven"><td>Chloride (mmol/L)</td></tr><tr class="tablerowodd"><td>Creatinine (umol/L)</td></tr><tr class="tableroweven"><td>Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>Glucose (mmol/L)</td></tr><tr class="tableroweven"><td>Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>Phosphate (mmol/L)</td></tr><tr class="tableroweven"><td>Protein (g/L)</td></tr><tr class="tablerowodd"><td>Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>Urate (umol/L)</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADLBCPV"><div class="codelist-caption">PARAM_ADLBCPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADLBCPV"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Urate (umol/L) change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADLBH"><div class="codelist-caption">PARAM_ADLBH<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADLBH"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Anisocytes</td></tr><tr class="tableroweven"><td>Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>Hematocrit</td></tr><tr class="tablerowodd"><td>Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>Lymphocytes (GI/L)</td></tr><tr class="tablerowodd"><td>Macrocytes</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tablerowodd"><td>Microcytes</td></tr><tr class="tableroweven"><td>Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>Platelet (GI/L)</td></tr><tr class="tableroweven"><td>Poikilocytes</td></tr><tr class="tablerowodd"><td>Polychromasia</td></tr><tr class="tableroweven"><td>Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>Leukocytes (GI/L)</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADLBHPV"><div class="codelist-caption">PARAM_ADLBHPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADLBHPV"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Microcytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Polychromasia change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADLBHY"><div class="codelist-caption">PARAM_ADLBHY<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADLBHY"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADQSADAS"><div class="codelist-caption">PARAM_ADQSADAS<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADQSADAS"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Word Recall Task</td></tr><tr class="tableroweven"><td>Naming Objects And Fingers (Refer To 5 C</td></tr><tr class="tablerowodd"><td>Delayed Word Recall</td></tr><tr class="tableroweven"><td>Commands</td></tr><tr class="tablerowodd"><td>Constructional Praxis</td></tr><tr class="tableroweven"><td>Ideational Praxis</td></tr><tr class="tablerowodd"><td>Orientation</td></tr><tr class="tableroweven"><td>Word Recognition</td></tr><tr class="tablerowodd"><td>Attention/Visual Search Task</td></tr><tr class="tableroweven"><td>Maze Solution</td></tr><tr class="tablerowodd"><td>Spoken Language Ability</td></tr><tr class="tableroweven"><td>Comprehension Of Spoken Language</td></tr><tr class="tablerowodd"><td>Word Finding Difficulty In Spontaneous S</td></tr><tr class="tableroweven"><td>Recall Of Test Instructions</td></tr><tr class="tablerowodd"><td>Adas-Cog(11) Subscore</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADQSCIBC"><div class="codelist-caption">PARAM_ADQSCIBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADQSCIBC"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>CIBIC Score</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADQSNPIX"><div class="codelist-caption">PARAM_ADQSNPIX<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADQSNPIX"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>NPI-X Item A (Delusion) Score</td></tr><tr class="tableroweven"><td>NPI-X Item B (Hallucination) Score</td></tr><tr class="tablerowodd"><td>NPI-X Item C (Agitation/Agression) Score</td></tr><tr class="tableroweven"><td>NPI-X Item D (Depression/Dysphoria) Score</td></tr><tr class="tablerowodd"><td>NPI-X Item E (Anxiety) Score</td></tr><tr class="tableroweven"><td>NPI-X Item F (Eupohoria/Elation) Score</td></tr><tr class="tablerowodd"><td>NPI-X Item G (Apathy/Indifference) Score</td></tr><tr class="tableroweven"><td>NPI-X Item H (Disinhibition) Score</td></tr><tr class="tablerowodd"><td>NPI-X Item I (Irritability/Lability) Score</td></tr><tr class="tableroweven"><td>NPI-X Item J (Aberrant Motor Behavior) Score</td></tr><tr class="tablerowodd"><td>NPI-X Item K (Night-time Behavior) Score</td></tr><tr class="tableroweven"><td>NPI-X Item L (Appetite/Eating Change) Score</td></tr><tr class="tablerowodd"><td>NPI-X (9) Total Score</td></tr><tr class="tableroweven"><td>Mean NPI-X (9) Total (Week 4 to 24)</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADTTE"><div class="codelist-caption">PARAM_ADTTE<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADTTE"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Time to First Dermatologic Event</td></tr></table></div><div class="codelist" id="CL.CL.PARAM_ADVS"><div class="codelist-caption">PARAM_ADVS<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - PARAM_ADVS"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>Weight (kg)</td></tr><tr class="tablerowodd"><td>Height (cm)</td></tr><tr class="tableroweven"><td>Temperature (C)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBC"><div class="codelist-caption">PARAMCD_ADLBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADLBC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALB</td><td class="codelist-item-decode">Albumin (g/L)</td></tr><tr class="tableroweven"><td>ALP</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L)</td></tr><tr class="tablerowodd"><td>ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>BILI</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>BUN</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tablerowodd"><td>CA</td><td class="codelist-item-decode">Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>CHOL</td><td class="codelist-item-decode">Cholesterol (mmol/L)</td></tr><tr class="tablerowodd"><td>CK</td><td class="codelist-item-decode">Creatine Kinase (U/L)</td></tr><tr class="tableroweven"><td>CL</td><td class="codelist-item-decode">Chloride (mmol/L)</td></tr><tr class="tablerowodd"><td>CREAT</td><td class="codelist-item-decode">Creatinine (umol/L)</td></tr><tr class="tableroweven"><td>GGT</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>GLUC</td><td class="codelist-item-decode">Glucose (mmol/L)</td></tr><tr class="tableroweven"><td>K</td><td class="codelist-item-decode">Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>PHOS</td><td class="codelist-item-decode">Phosphate (mmol/L)</td></tr><tr class="tableroweven"><td>PROT</td><td class="codelist-item-decode">Protein (g/L)</td></tr><tr class="tablerowodd"><td>SODIUM</td><td class="codelist-item-decode">Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>URATE</td><td class="codelist-item-decode">Urate (umol/L)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBCPV"><div class="codelist-caption">PARAMCD_ADLBCPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADLBCPV"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>_ALB</td><td class="codelist-item-decode">Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_ALP</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_BILI</td><td class="codelist-item-decode">Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_BUN</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CA</td><td class="codelist-item-decode">Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_CHOL</td><td class="codelist-item-decode">Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CK</td><td class="codelist-item-decode">Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_CL</td><td class="codelist-item-decode">Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CREAT</td><td class="codelist-item-decode">Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_GGT</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_GLUC</td><td class="codelist-item-decode">Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_K</td><td class="codelist-item-decode">Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_PHOS</td><td class="codelist-item-decode">Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_PROT</td><td class="codelist-item-decode">Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_SODIUM</td><td class="codelist-item-decode">Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_URATE</td><td class="codelist-item-decode">Urate (umol/L) change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBH"><div class="codelist-caption">PARAMCD_ADLBH<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADLBH"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ANISO</td><td class="codelist-item-decode">Anisocytes</td></tr><tr class="tableroweven"><td>BASO</td><td class="codelist-item-decode">Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>EOS</td><td class="codelist-item-decode">Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>HCT</td><td class="codelist-item-decode">Hematocrit</td></tr><tr class="tablerowodd"><td>HGB</td><td class="codelist-item-decode">Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>LYM</td><td class="codelist-item-decode">Lymphocytes (GI/L)</td></tr><tr class="tablerowodd"><td>MACROCY</td><td class="codelist-item-decode">Macrocytes</td></tr><tr class="tableroweven"><td>MCH</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>MCHC</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>MCV</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tablerowodd"><td>MICROCY</td><td class="codelist-item-decode">Microcytes</td></tr><tr class="tableroweven"><td>MONO</td><td class="codelist-item-decode">Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>PLAT</td><td class="codelist-item-decode">Platelet (GI/L)</td></tr><tr class="tableroweven"><td>POIKILO</td><td class="codelist-item-decode">Poikilocytes</td></tr><tr class="tablerowodd"><td>POLYCHR</td><td class="codelist-item-decode">Polychromasia</td></tr><tr class="tableroweven"><td>RBC</td><td class="codelist-item-decode">Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>WBC</td><td class="codelist-item-decode">Leukocytes (GI/L)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBHPV"><div class="codelist-caption">PARAMCD_ADLBHPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADLBHPV"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>_ANISO</td><td class="codelist-item-decode">Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_BASO</td><td class="codelist-item-decode">Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_EOS</td><td class="codelist-item-decode">Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_HCT</td><td class="codelist-item-decode">Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_HGB</td><td class="codelist-item-decode">Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_LYM</td><td class="codelist-item-decode">Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_MACROCY</td><td class="codelist-item-decode">Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_MCH</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_MCHC</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tableroweven"><td>_MCV</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_MICROCY</td><td class="codelist-item-decode">Microcytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_MONO</td><td class="codelist-item-decode">Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_PLAT</td><td class="codelist-item-decode">Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_POIKILO</td><td class="codelist-item-decode">Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_POLYCHR</td><td class="codelist-item-decode">Polychromasia change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_RBC</td><td class="codelist-item-decode">Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_WBC</td><td class="codelist-item-decode">Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBHY"><div class="codelist-caption">PARAMCD_ADLBHY<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADLBHY"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>BILI</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>BILIHY</td><td class="codelist-item-decode">Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>TRANSHY</td><td class="codelist-item-decode">Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>HYLAW</td><td class="codelist-item-decode">Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADQSADAS"><div class="codelist-caption">PARAMCD_ADQSADAS<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADQSADAS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ACITM01</td><td class="codelist-item-decode">Word Recall Task</td></tr><tr class="tableroweven"><td>ACITM02</td><td class="codelist-item-decode">Naming Objects And Fingers (Refer To 5 C</td></tr><tr class="tablerowodd"><td>ACITM03</td><td class="codelist-item-decode">Delayed Word Recall</td></tr><tr class="tableroweven"><td>ACITM04</td><td class="codelist-item-decode">Commands</td></tr><tr class="tablerowodd"><td>ACITM05</td><td class="codelist-item-decode">Constructional Praxis</td></tr><tr class="tableroweven"><td>ACITM06</td><td class="codelist-item-decode">Ideational Praxis</td></tr><tr class="tablerowodd"><td>ACITM07</td><td class="codelist-item-decode">Orientation</td></tr><tr class="tableroweven"><td>ACITM08</td><td class="codelist-item-decode">Word Recognition</td></tr><tr class="tablerowodd"><td>ACITM09</td><td class="codelist-item-decode">Attention/Visual Search Task</td></tr><tr class="tableroweven"><td>ACITM10</td><td class="codelist-item-decode">Maze Solution</td></tr><tr class="tablerowodd"><td>ACITM11</td><td class="codelist-item-decode">Spoken Language Ability</td></tr><tr class="tableroweven"><td>ACITM12</td><td class="codelist-item-decode">Comprehension Of Spoken Language</td></tr><tr class="tablerowodd"><td>ACITM13</td><td class="codelist-item-decode">Word Finding Difficulty In Spontaneous S</td></tr><tr class="tableroweven"><td>ACITM14</td><td class="codelist-item-decode">Recall Of Test Instructions</td></tr><tr class="tablerowodd"><td>ACTOT</td><td class="codelist-item-decode">Adas-Cog(11) Subscore</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADQSCIBC"><div class="codelist-caption">PARAMCD_ADQSCIBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADQSCIBC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CIBICVAL</td><td class="codelist-item-decode">CIBIC Score</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADQSNPIX"><div class="codelist-caption">PARAMCD_ADQSNPIX<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADQSNPIX"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>NPITM01S</td><td class="codelist-item-decode">NPI-X Item A (Delusion) Score</td></tr><tr class="tableroweven"><td>NPITM02S</td><td class="codelist-item-decode">NPI-X Item B (Hallucination) Score</td></tr><tr class="tablerowodd"><td>NPITM03S</td><td class="codelist-item-decode">NPI-X Item C (Agitation/Agression) Score</td></tr><tr class="tableroweven"><td>NPITM04S</td><td class="codelist-item-decode">NPI-X Item D (Depression/Dysphoria) Score</td></tr><tr class="tablerowodd"><td>NPITM05S</td><td class="codelist-item-decode">NPI-X Item E (Anxiety) Score</td></tr><tr class="tableroweven"><td>NPITM06S</td><td class="codelist-item-decode">NPI-X Item F (Eupohoria/Elation) Score</td></tr><tr class="tablerowodd"><td>NPITM07S</td><td class="codelist-item-decode">NPI-X Item G (Apathy/Indifference) Score</td></tr><tr class="tableroweven"><td>NPITM08S</td><td class="codelist-item-decode">NPI-X Item H (Disinhibition) Score</td></tr><tr class="tablerowodd"><td>NPITM09S</td><td class="codelist-item-decode">NPI-X Item I (Irritability/Lability) Score</td></tr><tr class="tableroweven"><td>NPITM10S</td><td class="codelist-item-decode">NPI-X Item J (Aberrant Motor Behavior) Score</td></tr><tr class="tablerowodd"><td>NPITM11S</td><td class="codelist-item-decode">NPI-X Item K (Night-time Behavior) Score</td></tr><tr class="tableroweven"><td>NPITM12S</td><td class="codelist-item-decode">NPI-X Item L (Appetite/Eating Change) Score</td></tr><tr class="tablerowodd"><td>NPTOT</td><td class="codelist-item-decode">NPI-X (9) Total Score</td></tr><tr class="tableroweven"><td>NPTOTMN</td><td class="codelist-item-decode">Mean NPI-X (9) Total (Week 4 to 24)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADTTE"><div class="codelist-caption">PARAMCD_ADTTE<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADTTE"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TTDE</td><td class="codelist-item-decode">Time to Derm. Event or End of Study</td></tr></table></div><div class="codelist" id="CL.CL.PARAMCD_ADVS"><div class="codelist-caption">PARAMCD_ADVS<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMCD_ADVS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SYSBP</td><td class="codelist-item-decode">Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>DIABP</td><td class="codelist-item-decode">Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>PULSE</td><td class="codelist-item-decode">Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>WEIGHT</td><td class="codelist-item-decode">Weight (kg)</td></tr><tr class="tablerowodd"><td>HEIGHT</td><td class="codelist-item-decode">Height (cm)</td></tr><tr class="tableroweven"><td>TEMP</td><td class="codelist-item-decode">Temperature (C)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBC"><div class="codelist-caption">PARAMN_ADLBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADLBC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>18</td><td class="codelist-item-decode">Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>19</td><td class="codelist-item-decode">Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>20</td><td class="codelist-item-decode">Chloride (mmol/L)</td></tr><tr class="tableroweven"><td>21</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tablerowodd"><td>22</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L)</td></tr><tr class="tableroweven"><td>23</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>25</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>26</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tableroweven"><td>27</td><td class="codelist-item-decode">Creatinine (umol/L)</td></tr><tr class="tablerowodd"><td>28</td><td class="codelist-item-decode">Urate (umol/L)</td></tr><tr class="tableroweven"><td>29</td><td class="codelist-item-decode">Phosphate (mmol/L)</td></tr><tr class="tablerowodd"><td>30</td><td class="codelist-item-decode">Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>31</td><td class="codelist-item-decode">Glucose (mmol/L)</td></tr><tr class="tablerowodd"><td>32</td><td class="codelist-item-decode">Protein (g/L)</td></tr><tr class="tableroweven"><td>33</td><td class="codelist-item-decode">Albumin (g/L)</td></tr><tr class="tablerowodd"><td>34</td><td class="codelist-item-decode">Cholesterol (mmol/L)</td></tr><tr class="tableroweven"><td>35</td><td class="codelist-item-decode">Creatine Kinase (U/L)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBCPV"><div class="codelist-caption">PARAMN_ADLBCPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADLBCPV"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>118</td><td class="codelist-item-decode">Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>119</td><td class="codelist-item-decode">Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>120</td><td class="codelist-item-decode">Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>121</td><td class="codelist-item-decode">Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>122</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>123</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>124</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>125</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>126</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>127</td><td class="codelist-item-decode">Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>128</td><td class="codelist-item-decode">Urate (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>129</td><td class="codelist-item-decode">Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>130</td><td class="codelist-item-decode">Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>131</td><td class="codelist-item-decode">Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>132</td><td class="codelist-item-decode">Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>133</td><td class="codelist-item-decode">Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>134</td><td class="codelist-item-decode">Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>135</td><td class="codelist-item-decode">Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBH"><div class="codelist-caption">PARAMN_ADLBH<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADLBH"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Hematocrit</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Leukocytes (GI/L)</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">Lymphocytes (GI/L)</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">Platelet (GI/L)</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">Anisocytes</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Macrocytes</td></tr><tr class="tablerowodd"><td>15</td><td class="codelist-item-decode">Microcytes</td></tr><tr class="tableroweven"><td>16</td><td class="codelist-item-decode">Poikilocytes</td></tr><tr class="tablerowodd"><td>17</td><td class="codelist-item-decode">Polychromasia</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBHPV"><div class="codelist-caption">PARAMN_ADLBHPV<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADLBHPV"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>101</td><td class="codelist-item-decode">Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>102</td><td class="codelist-item-decode">Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>103</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>104</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>105</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tableroweven"><td>106</td><td class="codelist-item-decode">Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>107</td><td class="codelist-item-decode">Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>108</td><td class="codelist-item-decode">Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>109</td><td class="codelist-item-decode">Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>110</td><td class="codelist-item-decode">Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>111</td><td class="codelist-item-decode">Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>112</td><td class="codelist-item-decode">Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>113</td><td class="codelist-item-decode">Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>114</td><td class="codelist-item-decode">Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>115</td><td class="codelist-item-decode">Microcytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>116</td><td class="codelist-item-decode">Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>117</td><td class="codelist-item-decode">Polychromasia change from previous visit, relative to normal range</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBHY"><div class="codelist-caption">PARAMN_ADLBHY<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADLBHY"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADQSADAS"><div class="codelist-caption">PARAMN_ADQSADAS<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADQSADAS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Word Recall Task</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Naming Objects And Fingers (Refer To 5 C</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Delayed Word Recall</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Commands</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Constructional Praxis</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Ideational Praxis</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">Orientation</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">Word Recognition</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">Attention/Visual Search Task</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">Maze Solution</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">Spoken Language Ability</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Comprehension Of Spoken Language</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">Word Finding Difficulty In Spontaneous S</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Recall Of Test Instructions</td></tr><tr class="tablerowodd"><td>15</td><td class="codelist-item-decode">Adas-Cog(11) Subscore</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADQSCIBC"><div class="codelist-caption">PARAMN_ADQSCIBC<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADQSCIBC"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">CIBIC Score</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADQSNPIX"><div class="codelist-caption">PARAMN_ADQSNPIX<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADQSNPIX"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">NPI-X Item A (Delusion) Score</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">NPI-X Item B (Hallucination) Score</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">NPI-X Item C (Agitation/Agression) Score</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">NPI-X Item D (Depression/Dysphoria) Score</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">NPI-X Item E (Anxiety) Score</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">NPI-X Item F (Eupohoria/Elation) Score</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">NPI-X Item G (Apathy/Indifference) Score</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">NPI-X Item H (Disinhibition) Score</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">NPI-X Item I (Irritability/Lability) Score</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">NPI-X Item J (Aberrant Motor Behavior) Score</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">NPI-X Item K (Night-time Behavior) Score</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">NPI-X Item L (Appetite/Eating Change) Score</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">NPI-X (9) Total Score</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Mean NPI-X (9) Total (Week 4 to 24)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMN_ADVS"><div class="codelist-caption">PARAMN_ADVS<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMN_ADVS"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Weight (kg)</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Height (cm)</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Temperature (C)</td></tr></table></div><div class="codelist" id="CL.CL.PARAMTYP"><div class="codelist-caption">PARAMTYP<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - PARAMTYP"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DERIVED</td><td class="codelist-item-decode">DERIVED</td></tr></table></div><div class="codelist" id="CL.CL.RACE"><div class="codelist-caption">Race [<span class="nci">C74457</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Code List - Race"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>WHITE [<span class="nci">C41261</span>]</td></tr><tr class="tableroweven"><td>BLACK OR AFRICAN AMERICAN [<span class="nci">C16352</span>]</td></tr><tr class="tablerowodd"><td>AMERICAN INDIAN OR ALASKA NATIVE [<span class="nci">C41259</span>]</td></tr><tr class="tableroweven"><td>ASIAN [<span class="nci">C41260</span>]</td></tr></table></div><div class="codelist" id="CL.CL.RACEN"><div class="codelist-caption">Race (N)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Race (N)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">WHITE</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">BLACK OR AFRICAN AMERICAN</td></tr><tr class="tablerowodd"><td>6</td><td class="codelist-item-decode">AMERICAN INDIAN OR ALASKA NATIVE</td></tr><tr class="tableroweven"><td>7</td><td class="codelist-item-decode">ASIAN</td></tr></table></div><div class="codelist" id="CL.CL.SEX"><div class="codelist-caption">Sex [<span class="nci">C66731</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Sex"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>F [<span class="nci">C16576</span>]</td><td class="codelist-item-decode">Female</td></tr><tr class="tableroweven"><td>M [<span class="nci">C20197</span>]</td><td class="codelist-item-decode">Male</td></tr><tr class="tablerowodd"><td>U [<span class="nci">C66731</span>]</td><td class="codelist-item-decode">U; UNK; Unknown</td></tr></table></div><div class="codelist" id="CL.CL.SHIFT"><div class="codelist-caption">Shift<span class="standard-refeference">[Non Standard]</span></div><table summary="Code List - Shift"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>High to Normal</td></tr><tr class="tableroweven"><td>Normal to Normal</td></tr><tr class="tablerowodd"><td>Normal to High</td></tr></table></div><div class="codelist" id="CL.CL.SHIFTN"><div class="codelist-caption">Shift (N)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - Shift (N)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">High to Normal</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Normal to Normal</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Normal to High</td></tr></table></div><div class="codelist" id="CL.CL.Y_BLANK"><div class="codelist-caption">Y Only [<span class="nci">C66742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - Y Only"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Y [<span class="nci">C49488</span>]</td><td class="codelist-item-decode">Yes</td></tr></table></div><div class="codelist" id="CL.CL.YN"><div class="codelist-caption">No Yes Response [<span class="nci">C66742</span>]<span class="standard-refeference">[CDISC/NCI SDTM 2020-12-18]</span></div><table summary="Controlled Term - No Yes Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>N [<span class="nci">C49487</span>]</td><td class="codelist-item-decode">No</td></tr><tr class="tableroweven"><td>Y [<span class="nci">C49488</span>]</td><td class="codelist-item-decode">Yes</td></tr></table></div><div class="codelist" id="CL.CL.YNN"><div class="codelist-caption">No Yes Response (N)<span class="standard-refeference">[Non Standard]</span></div><table summary="Controlled Term - No Yes Response (N)"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Yes</td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div><a id="externaldictionary"></a><h1 class="invisible">External Dictionaries</h1><div class="containerbox"><table summary="External Dictionaries (MedDra, WHODRUG, ...)"><caption class="header">External Dictionaries</caption><tr class="header"><th scope="col">Reference Name</th><th scope="col">External Dictionary</th><th scope="col">Dictionary Version</th></tr><tr id="CL.CL.AEDICT" class="tablerowodd"><td>ADVERSE EVENT DICTIONARY</td><td>MedDRA</td><td>8.0</td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="compmethod"></a><div class="containerbox"><h1 class="invisible">Methods</h1><table summary="Methods"><caption class="header">Methods</caption><tr class="header"><th scope="col">Method</th><th scope="col">Type</th><th scope="col">Description</th></tr><tr id="MT.MT.ABLFL" class="tablerowodd"><td>Algorithm to derive ABLFL</td><td>Computation</td><td><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr id="MT.MT.ADADAS.ADT" class="tableroweven"><td>Algorithm to derive ADADAS.ADT</td><td>Computation</td><td><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr id="MT.MT.ADADAS.ANL01FL" class="tablerowodd"><td>Algorithm to derive ADADAS.ANL01FL</td><td>Computation</td><td><div class="method-code">If multiple visits fall into the same visit window, then the one closest to the target date is chosen for analysis. These are flagged with ANL01FL="Y".</div></td></tr><tr id="MT.MT.ADADAS.AVAL.ACTOT" class="tableroweven"><td>Algorithm to derive ADADAS.AVAL.ACTOT</td><td>Computation</td><td><div class="method-code">Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see SAP section 14.2 for details on adjusting for missing values.</div></td></tr><tr id="MT.MT.ADADAS.AVISIT" class="tablerowodd"><td>Algorithm to derive ADADAS.AVISIT</td><td>Computation</td><td><div class="method-code">Derived based on windowing algorithm described in SAP, Section 8.2</div></td></tr><tr id="MT.MT.ADADAS.AWHI" class="tableroweven"><td>Algorithm to derive ADADAS.AWHI</td><td>Computation</td><td><div class="method-code">End day of the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADADAS.AWLO" class="tablerowodd"><td>Algorithm to derive ADADAS.AWLO</td><td>Computation</td><td><div class="method-code">Start day of the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADADAS.AWRANGE" class="tableroweven"><td>Algorithm to derive ADADAS.AWRANGE</td><td>Computation</td><td><div class="method-code">Window range, specified in the SAP.</div></td></tr><tr id="MT.MT.ADADAS.AWTARGET" class="tablerowodd"><td>Algorithm to derive ADADAS.AWTARGET</td><td>Computation</td><td><div class="method-code">Target day within the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADADAS.AWTDIFF" class="tableroweven"><td>Algorithm to derive ADADAS.AWTDIFF</td><td>Computation</td><td><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr id="MT.MT.ADADAS.AWU" class="tablerowodd"><td>Algorithm to derive ADADAS.AWU</td><td>Computation</td><td><div class="method-code">Assigned as "DAYS".</div></td></tr><tr id="MT.MT.ADADAS.BASE" class="tableroweven"><td>Algorithm to derive ADADAS.BASE</td><td>Computation</td><td><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)</div></td></tr><tr id="MT.MT.ADAE.ADURN" class="tablerowodd"><td>Algorithm to derive ADAE.ADURN</td><td>Computation</td><td><div class="method-code">ADURN=AENDT-ASTDT+1</div></td></tr><tr id="MT.MT.ADAE.ADURU" class="tableroweven"><td>Algorithm to derive ADAE.ADURU</td><td>Computation</td><td><div class="method-code">If ADURN is not missing then ADURU='DAY'</div></td></tr><tr id="MT.MT.ADAE.AENDT" class="tablerowodd"><td>Algorithm to derive ADAE.AENDT</td><td>Computation</td><td><div class="method-code">AE.AEENDTC, converted to a numeric SAS date</div></td></tr><tr id="MT.MT.ADAE.AENDY" class="tableroweven"><td>Algorithm to derive ADAE.AENDY</td><td>Computation</td><td><div class="method-code">IF AENDT&gt;=TRTSDT&gt;MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT&gt;AENDT&gt;MISSING then AENDY=AENDT-TRTSDT</div></td></tr><tr id="MT.MT.ADAE.AOCC01FL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCC01FL</td><td>Computation</td><td><div class="method-code">Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=?Y?) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)</div></td></tr><tr id="MT.MT.ADAE.AOCC02FL" class="tableroweven"><td>Algorithm to derive ADAE.AOCC02FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=?Y?) within each Subject</div></td></tr><tr id="MT.MT.ADAE.AOCC03FL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCC03FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=?Y?) within each Subject and SOC</div></td></tr><tr id="MT.MT.ADAE.AOCC04FL" class="tableroweven"><td>Algorithm to derive ADAE.AOCC04FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr id="MT.MT.ADAE.AOCCFL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCCFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=?Y?) within each Subject</div></td></tr><tr id="MT.MT.ADAE.AOCCPFL" class="tableroweven"><td>Algorithm to derive ADAE.AOCCPFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr id="MT.MT.ADAE.AOCCSFL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCCSFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=?Y?) within each Subject and SOC</div></td></tr><tr id="MT.MT.ADAE.ASTDT" class="tableroweven"><td>Algorithm to derive ADAE.ASTDT</td><td>Computation</td><td><div class="method-code">AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.</div></td></tr><tr id="MT.MT.ADAE.ASTDTF" class="tablerowodd"><td>Algorithm to derive ADAE.ASTDTF</td><td>Computation</td><td><div class="method-code">ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study.</div></td></tr><tr id="MT.MT.ADAE.ASTDY" class="tableroweven"><td>Algorithm to derive ADAE.ASTDY</td><td>Computation</td><td><div class="method-code">IF ASTDT&gt;=TRTSDT&gt;MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT&gt;ASTDT&gt;MISSING then ASTDY=ASTDT-TRTSDT</div></td></tr><tr id="MT.MT.ADAE.CQ01NAM" class="tablerowodd"><td>Algorithm to derive ADAE.CQ01NAM</td><td>Computation</td><td><div class="method-code">If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL</div></td></tr><tr id="MT.MT.ADAE.TRTEMFL" class="tableroweven"><td>Algorithm to derive ADAE.TRTEMFL</td><td>Computation</td><td><div class="method-code">If ASTDT &gt;= TRTSDT &gt; . then TRTEMFL='Y'. Otherwise TRTEMFL='N'</div></td></tr><tr id="MT.MT.ADCIBC.ADT" class="tablerowodd"><td>Algorithm to derive ADCIBC.ADT</td><td>Computation</td><td><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr id="MT.MT.ADCIBC.ANL01FL" class="tableroweven"><td>Algorithm to derive ADCIBC.ANL01FL</td><td>Computation</td><td><div class="method-code">Set ANL01FL=Y based on SAP Page 10 analysis windows.</div></td></tr><tr id="MT.MT.ADCIBC.AVISIT" class="tablerowodd"><td>Algorithm to derive ADCIBC.AVISIT</td><td>Computation</td><td><div class="method-code">Character version of the visit.</div></td></tr><tr id="MT.MT.ADCIBC.AWHI" class="tableroweven"><td>Algorithm to derive ADCIBC.AWHI</td><td>Computation</td><td><div class="method-code">End day of the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADCIBC.AWLO" class="tablerowodd"><td>Algorithm to derive ADCIBC.AWLO</td><td>Computation</td><td><div class="method-code">Start day of the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADCIBC.AWRANGE" class="tableroweven"><td>Algorithm to derive ADCIBC.AWRANGE</td><td>Computation</td><td><div class="method-code">Window range, specified in the SAP.</div></td></tr><tr id="MT.MT.ADCIBC.AWTARGET" class="tablerowodd"><td>Algorithm to derive ADCIBC.AWTARGET</td><td>Computation</td><td><div class="method-code">Target day within the window, specified in the SAP.</div></td></tr><tr id="MT.MT.ADCIBC.AWTDIFF" class="tableroweven"><td>Algorithm to derive ADCIBC.AWTDIFF</td><td>Computation</td><td><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr id="MT.MT.ADCIBC.AWU" class="tablerowodd"><td>Algorithm to derive ADCIBC.AWU</td><td>Computation</td><td><div class="method-code">Assigned as "DAYS".</div></td></tr><tr id="MT.MT.ADLBC.ADT" class="tableroweven"><td>Algorithm to derive ADLBC.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBC.AENTMTFL" class="tablerowodd"><td>Algorithm to derive ADLBC.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab parameter during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBC.ANL01FL" class="tableroweven"><td>Algorithm to derive ADLBC.ANL01FL</td><td>Computation</td><td><div class="method-code">Y if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive, null otherwise; only the first on-treatment AVAL that has absolute val equal to the max is flagged.</div></td></tr><tr id="MT.MT.ADLBC.ANRIND" class="tablerowodd"><td>Algorithm to derive ADLBC.ANRIND</td><td>Computation</td><td><div class="method-code">if AVAL &lt; (0.5*LBSTNRLO) then ANRIND='L'.
Else if AVAL &gt; 1.5* LBSTNRHI then ANRIND='H'.
ANRIND='N' otherwise. Used for shift tables</div></td></tr><tr id="MT.MT.ADLBC.AVISIT" class="tableroweven"><td>Algorithm to derive ADLBC.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBC.BASE" class="tablerowodd"><td>Algorithm to derive ADLBC.BASE</td><td>Computation</td><td><div class="method-code">ADLBC.LBSTRESN when ADLBC.ABLFL=Y</div></td></tr><tr id="MT.MT.ADLBC.BR2A1HI" class="tableroweven"><td>Algorithm to derive ADLBC.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBC.BR2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBC.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBC.PARAM" class="tableroweven"><td>Algorithm to derive ADLBC.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100L same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBC.PARAMCD" class="tablerowodd"><td>Algorithm to derive ADLBC.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBC.R2A1HI" class="tableroweven"><td>Algorithm to derive ADLBC.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBC.R2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBC.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBCPV.ADT" class="tableroweven"><td>Algorithm to derive ADLBCPV.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBCPV.AENTMTFL" class="tablerowodd"><td>Algorithm to derive ADLBCPV.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab parameter during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBCPV.ANL01FL" class="tableroweven"><td>Algorithm to derive ADLBCPV.ANL01FL</td><td>Computation</td><td><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr id="MT.MT.ADLBCPV.ANRIND" class="tablerowodd"><td>Algorithm to derive ADLBCPV.ANRIND</td><td>Computation</td><td><div class="method-code">if AVAL &lt; -1 then ANRIND='L'.
If AVAL &gt; 1 then ANRIND='H'.
ANRIND='N' otherwise.
Null if LBBLFL=Y or AVAL=null</div></td></tr><tr id="MT.MT.ADLBCPV.AVAL" class="tableroweven"><td>Algorithm to derive ADLBCPV.AVAL</td><td>Computation</td><td><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr id="MT.MT.ADLBCPV.AVISIT" class="tablerowodd"><td>Algorithm to derive ADLBCPV.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBCPV.BASE" class="tableroweven"><td>Algorithm to derive ADLBCPV.BASE</td><td>Computation</td><td><div class="method-code">ADLBCPV.LBSTRESN when ADLBCPV.ABLFL=Y</div></td></tr><tr id="MT.MT.ADLBCPV.BR2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBCPV.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBCPV.BR2A1LO" class="tableroweven"><td>Algorithm to derive ADLBCPV.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBCPV.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBCPV.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBCPV.PARAMCD" class="tableroweven"><td>Algorithm to derive ADLBCPV.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBCPV.R2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBCPV.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBCPV.R2A1LO" class="tableroweven"><td>Algorithm to derive ADLBCPV.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBH.ADT" class="tablerowodd"><td>Algorithm to derive ADLBH.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBH.AENTMTFL" class="tableroweven"><td>Algorithm to derive ADLBH.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab test during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBH.ANL01FL" class="tablerowodd"><td>Algorithm to derive ADLBH.ANL01FL</td><td>Computation</td><td><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr id="MT.MT.ADLBH.ANRIND" class="tableroweven"><td>Algorithm to derive ADLBH.ANRIND</td><td>Computation</td><td><div class="method-code">If AVAL &lt; (0.5*LBSTNRLO) then ANRIND='L'.
If LAVAL &gt; 1.5* LBSTNRHI then ANRIND='H'. ANRIND='N' otherwise.
Used for shift tables.</div></td></tr><tr id="MT.MT.ADLBH.AVISIT" class="tablerowodd"><td>Algorithm to derive ADLBH.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBH.BASE" class="tableroweven"><td>Algorithm to derive ADLBH.BASE</td><td>Computation</td><td><div class="method-code">LBSTRESN when ADLBC.ABLFL=Y</div></td></tr><tr id="MT.MT.ADLBH.BR2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBH.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBH.BR2A1LO" class="tableroweven"><td>Algorithm to derive ADLBH.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBH.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBH.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LBTEST concatenated with LBSTRESU.
For PARAMN&gt;100: LBTEST concatenated with LB.LBSTRESU concatenated with "change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBH.PARAMCD" class="tableroweven"><td>Algorithm to derive ADLBH.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBH.R2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBH.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBH.R2A1LO" class="tableroweven"><td>Algorithm to derive ADLBH.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBHPV.ADT" class="tablerowodd"><td>Algorithm to derive ADLBHPV.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBHPV.AENTMTFL" class="tableroweven"><td>Algorithm to derive ADLBHPV.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab test during treatment phase:
'Y' if VISITNUM=12.
If subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBHPV.ANL01FL" class="tablerowodd"><td>Algorithm to derive ADLBHPV.ANL01FL</td><td>Computation</td><td><div class="method-code">Y' if the absolute value of this AVAL is the largest for the subject for VISITS 4-12 inclusive.
Null otherwise.
Only the first on-treatment AVAL that has absolute val equal to the max is flagged</div></td></tr><tr id="MT.MT.ADLBHPV.ANRIND" class="tableroweven"><td>Algorithm to derive ADLBHPV.ANRIND</td><td>Computation</td><td><div class="method-code">If AVAL &lt; -1 then ANRIND='L'.
If AVAL &gt; 1 then ANRIND='H'.
ANRIND='N' otherwise.
Null if LBBLFL=Y or AVAL=null</div></td></tr><tr id="MT.MT.ADLBHPV.AVAL" class="tablerowodd"><td>Algorithm to derive ADLBHPV.AVAL</td><td>Computation</td><td><div class="method-code">(LBSTRESN - previous LBSTRESN)/(.5*(LBSTNRHI-LBSTNRLO)).
Null if LBBLFL=Y</div></td></tr><tr id="MT.MT.ADLBHPV.AVISIT" class="tableroweven"><td>Algorithm to derive ADLBHPV.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBHPV.BASE" class="tablerowodd"><td>Algorithm to derive ADLBHPV.BASE</td><td>Computation</td><td><div class="method-code">ADLBHPV.LBSTRESN when ADLBHPV.ABLFL=Y</div></td></tr><tr id="MT.MT.ADLBHPV.BR2A1HI" class="tableroweven"><td>Algorithm to derive ADLBHPV.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBHPV.BR2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBHPV.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBHPV.PARAM" class="tableroweven"><td>Algorithm to derive ADLBHPV.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LB.LBTEST concatenated with LB.LBSTRESU.
For PARAMN&gt;100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBHPV.PARAMCD" class="tablerowodd"><td>Algorithm to derive ADLBHPV.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN&lt;100: same as LBTESTCD.
For PARAMN&gt;100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBHPV.R2A1HI" class="tableroweven"><td>Algorithm to derive ADLBHPV.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBHPV.R2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBHPV.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBHY.ADT" class="tableroweven"><td>Algorithm to derive ADLBHY.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBHY.AVAL.BILIHY" class="tablerowodd"><td>Algorithm to derive ADLBHY.AVAL.BILIHY</td><td>Computation</td><td><div class="method-code">For a given visit, if param='BILI' and r2a1hi &gt; 1.5 then aval=1.
Otherwise if param='BILI' then aval=0</div></td></tr><tr id="MT.MT.ADLBHY.AVAL.HYLAW" class="tableroweven"><td>Algorithm to derive ADLBHY.AVAL.HYLAW</td><td>Computation</td><td><div class="method-code">For a given visit, if param='BILHY' or 'TRANSHY' and if both has aval=1 then for this param then aval=1.
Otherwise if for a given visit, if param='BILHY' or 'TRANSHY' then aval=0.</div></td></tr><tr id="MT.MT.ADLBHY.AVAL.TRANSHY" class="tablerowodd"><td>Algorithm to derive ADLBHY.AVAL.TRANSHY</td><td>Computation</td><td><div class="method-code">For a given visit, if param='ALT' or 'AST' and if either r2a1hi &gt; 1.5 then aval=1.
Otherwise if param='ALT' or 'AST' then aval=0</div></td></tr><tr id="MT.MT.ADLBHY.AVISIT" class="tableroweven"><td>Algorithm to derive ADLBHY.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBHY.BASE" class="tablerowodd"><td>Algorithm to derive ADLBHY.BASE</td><td>Computation</td><td><div class="method-code">ADLBC.AVAL when ADLBC.ABLFL=Y</div></td></tr><tr id="MT.MT.ADLBHY.CRIT1FL" class="tableroweven"><td>Algorithm to derive ADLBHY.CRIT1FL</td><td>Computation</td><td><div class="method-code">If R21AHI &gt; 1.5 then set to 'Y'.
If R2A1HI is not missing then set to 'N'.
Else set to missing.</div></td></tr><tr id="MT.MT.ADLBHY.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBHY.PARAM</td><td>Computation</td><td><div class="method-code">same as LBTEST concatenated with LBSTRESU except for hylaw params</div></td></tr><tr id="MT.MT.ADNPIX.ADT" class="tableroweven"><td>Algorithm to derive ADNPIX.ADT</td><td>Computation</td><td><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr id="MT.MT.ADNPIX.ANL01FL" class="tablerowodd"><td>Algorithm to derive ADNPIX.ANL01FL</td><td>Computation</td><td><div class="method-code">Set ANL01FL=Y based on SAP Page 10 analysis windows.</div></td></tr><tr id="MT.MT.ADNPIX.AVAL.NPTOTMN" class="tableroweven"><td>Algorithm to derive ADNPIX.AVAL.NPTOTMN</td><td>Computation</td><td><div class="method-code">take the mean of AVAL when PARAMCD=NPTOT from week 4 to 24.</div></td></tr><tr id="MT.MT.ADNPIX.AVISIT" class="tablerowodd"><td>Algorithm to derive ADNPIX.AVISIT</td><td>Computation</td><td><div class="method-code">Character version of the visit.</div></td></tr><tr id="MT.MT.ADNPIX.AWHI" class="tableroweven"><td>Algorithm to derive ADNPIX.AWHI</td><td>Computation</td><td><div class="method-code">End day of the window, specified in the SAP Page 10.</div></td></tr><tr id="MT.MT.ADNPIX.AWLO" class="tablerowodd"><td>Algorithm to derive ADNPIX.AWLO</td><td>Computation</td><td><div class="method-code">Start day of the window, specified in the SAP Page 10.</div></td></tr><tr id="MT.MT.ADNPIX.AWRANGE" class="tableroweven"><td>Algorithm to derive ADNPIX.AWRANGE</td><td>Computation</td><td><div class="method-code">Window range, specified in the SAP Page 10.</div></td></tr><tr id="MT.MT.ADNPIX.AWTARGET" class="tablerowodd"><td>Algorithm to derive ADNPIX.AWTARGET</td><td>Computation</td><td><div class="method-code">Target day within the window, specified in the SAP Page 10.</div></td></tr><tr id="MT.MT.ADNPIX.AWTDIFF" class="tableroweven"><td>Algorithm to derive ADNPIX.AWTDIFF</td><td>Computation</td><td><div class="method-code">Absolute difference between AWTARGET and ADY</div></td></tr><tr id="MT.MT.ADNPIX.AWU" class="tablerowodd"><td>Algorithm to derive ADNPIX.AWU</td><td>Computation</td><td><div class="method-code">Assigned as "DAYS".</div></td></tr><tr id="MT.MT.ADNPIX.BASE" class="tableroweven"><td>Algorithm to derive ADNPIX.BASE</td><td>Computation</td><td><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y.</div></td></tr><tr id="MT.MT.ADSL.AGEGR1" class="tablerowodd"><td>Algorithm to derive ADSL.AGEGR1</td><td>Computation</td><td><div class="method-code">Character variable derived from ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADSL.AGEGR1N" class="tableroweven"><td>Algorithm to derive ADSL.AGEGR1N</td><td>Computation</td><td><div class="method-code">AGEGR1 = 1 if AGE &lt;65.
AGEGR1 = 2 if AGE 65-80.
AGEGR1 = 3 if AGE &gt;80.</div></td></tr><tr id="MT.MT.ADSL.AVGDD" class="tablerowodd"><td>Algorithm to derive ADSL.AVGDD</td><td>Computation</td><td><div class="method-code">CUMDOSE/TRTDUR</div></td></tr><tr id="MT.MT.ADSL.BMIBL" class="tableroweven"><td>Algorithm to derive ADSL.BMIBL</td><td>Computation</td><td><div class="method-code">WEIGHTBL / ((HEIGHTBL*100)**2)</div></td></tr><tr id="MT.MT.ADSL.BMIBLGR1" class="tablerowodd"><td>Algorithm to derive ADSL.BMIBLGR1</td><td>Computation</td><td><div class="method-code">BMIBLGR1=Normal if . &lt; BMIBL &lt;25.
BMIBLGR1=Overweight if 25 &lt;=BMIBL &lt;30.
BMIBLGR1=Obese if BMIBL &gt;=30.</div></td></tr><tr id="MT.MT.ADSL.COMP16FL" class="tableroweven"><td>Algorithm to derive ADSL.COMP16FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=10 and ENDDT&gt;=date of visit 10, N otherwise</div></td></tr><tr id="MT.MT.ADSL.COMP24FL" class="tablerowodd"><td>Algorithm to derive ADSL.COMP24FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=12 and ENDDT&gt;= date of visit 12 , N otherwise</div></td></tr><tr id="MT.MT.ADSL.COMP8FL" class="tableroweven"><td>Algorithm to derive ADSL.COMP8FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=8 and ENDDT &gt;= date of visit 8, N otherwise</div></td></tr><tr id="MT.MT.ADSL.CUMDOSE" class="tablerowodd"><td>Algorithm to derive ADSL.CUMDOSE</td><td>Computation</td><td><div class="method-code">For ARMN=0 or 1: CUMDOSE=TRT01PN*TRTDUR. ---
For ARMN=2: CUMDOSE will be based on 54mg per day for the # of days subj was in 1st dosing interval (i.e., visit4date-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subj discontinued &lt;=visit 4 and &gt; visit 3), 81mg per day for the # of days subj was in 2nd dosing interval (i.e., visit12date-visit4date if 2nd interval completed, TRTEDT-visit4date if subj discontinued &lt;= visit 12 and &gt; visit 4), and 54mg per day for the # of days subj was in 3rd dosing interval (i.e., TRTEDT - visit12date if subj continued after visit 12).</div></td></tr><tr id="MT.MT.ADSL.DCDECOD" class="tableroweven"><td>Algorithm to derive ADSL.DCDECOD</td><td>Computation</td><td><div class="method-code">DS.DSDECOD where DSCAT='DISPOSITION EVENT'</div></td></tr><tr id="MT.MT.ADSL.DCREASCD" class="tablerowodd"><td>Algorithm to derive ADSL.DCREASCD</td><td>Computation</td><td><div class="method-code">Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation</div></td></tr><tr id="MT.MT.ADSL.DISCONFL" class="tableroweven"><td>Algorithm to derive ADSL.DISCONFL</td><td>Computation</td><td><div class="method-code">Y if DCREASCD ^= 'Completed'. Null otherwise</div></td></tr><tr id="MT.MT.ADSL.DISONSDT" class="tablerowodd"><td>Algorithm to derive ADSL.DISONSDT</td><td>Computation</td><td><div class="method-code">MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.DSRAEFL" class="tableroweven"><td>Algorithm to derive ADSL.DSRAEFL</td><td>Computation</td><td><div class="method-code">Y if DCREASCD='Adverse Event'. Null otherwise</div></td></tr><tr id="MT.MT.ADSL.DURDIS" class="tablerowodd"><td>Algorithm to derive ADSL.DURDIS</td><td>Computation</td><td><div class="method-code">number of months between VISIT1DT and DISONSET</div></td></tr><tr id="MT.MT.ADSL.DURDSGR1" class="tableroweven"><td>Algorithm to derive ADSL.DURDSGR1</td><td>Computation</td><td><div class="method-code">grouping DURDIS values as &lt;12 and &gt;=12</div></td></tr><tr id="MT.MT.ADSL.EDUCLVL" class="tablerowodd"><td>Algorithm to derive ADSL.EDUCLVL</td><td>Computation</td><td><div class="method-code">SC.SCSTRESN where SC.SCTESTCD=YEARSEDU</div></td></tr><tr id="MT.MT.ADSL.EFFFL" class="tableroweven"><td>Algorithm to derive ADSL.EFFFL</td><td>Computation</td><td><div class="method-code">Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM&gt;3 AND at least one record in QS for CIBIC+ with VISITNUM&gt;3.
N otherwise</div></td></tr><tr id="MT.MT.ADSL.EOSSTT" class="tablerowodd"><td>Algorithm to derive ADSL.EOSSTT</td><td>Computation</td><td><div class="method-code">COMPLETED if ADSL.DCDECOD='COMPLETED'. DISCONTINUED if ADSL.DCDECOD not equal to COMPLETED.</div></td></tr><tr id="MT.MT.ADSL.HEIGHTBL" class="tableroweven"><td>Algorithm to derive ADSL.HEIGHTBL</td><td>Computation</td><td><div class="method-code">VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1</div></td></tr><tr id="MT.MT.ADSL.ITTFL" class="tablerowodd"><td>Algorithm to derive ADSL.ITTFL</td><td>Computation</td><td><div class="method-code">Y if ARMCD ne ' '. N otherwise</div></td></tr><tr id="MT.MT.ADSL.MMSETOT" class="tableroweven"><td>Algorithm to derive ADSL.MMSETOT</td><td>Computation</td><td><div class="method-code">sum of QS.QSORRES values for the subject</div></td></tr><tr id="MT.MT.ADSL.RACEN" class="tablerowodd"><td>Algorithm to derive ADSL.RACEN</td><td>Computation</td><td><div class="method-code">Numeric code for RACE</div></td></tr><tr id="MT.MT.ADSL.RFENDT" class="tableroweven"><td>Algorithm to derive ADSL.RFENDT</td><td>Computation</td><td><div class="method-code">RFENDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.SAFFL" class="tablerowodd"><td>Algorithm to derive ADSL.SAFFL</td><td>Computation</td><td><div class="method-code">Y if ITTFL='Y' and TRTSDT ne missing. N otherwise</div></td></tr><tr id="MT.MT.ADSL.SITEGR1" class="tableroweven"><td>Algorithm to derive ADSL.SITEGR1</td><td>Computation</td><td><div class="method-code">Refer to SAP, Section 7.1.
If not pooled then SITEGR1=SITEID.
If pooled, SITEGR1 will be 900</div></td></tr><tr id="MT.MT.ADSL.TRT01A" class="tablerowodd"><td>Algorithm to derive ADSL.TRT01A</td><td>Computation</td><td><div class="method-code">TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.</div></td></tr><tr id="MT.MT.ADSL.TRT01AN" class="tableroweven"><td>Algorithm to derive ADSL.TRT01AN</td><td>Computation</td><td><div class="method-code">Numeric code for TRT01A which corresponds to the randomized dose</div></td></tr><tr id="MT.MT.ADSL.TRT01PN" class="tablerowodd"><td>Algorithm to derive ADSL.TRT01PN</td><td>Computation</td><td><div class="method-code">Numeric code for TRT01P which corresponds to the randomized dose</div></td></tr><tr id="MT.MT.ADSL.TRTDUR" class="tableroweven"><td>Algorithm to derive ADSL.TRTDUR</td><td>Computation</td><td><div class="method-code">TRTEDT-TRTSDT+1</div></td></tr><tr id="MT.MT.ADSL.TRTEDT" class="tablerowodd"><td>Algorithm to derive ADSL.TRTEDT</td><td>Computation</td><td><div class="method-code">The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.</div></td></tr><tr id="MT.MT.ADSL.TRTSDT" class="tableroweven"><td>Algorithm to derive ADSL.TRTSDT</td><td>Computation</td><td><div class="method-code">SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.VISIT1DT" class="tablerowodd"><td>Algorithm to derive ADSL.VISIT1DT</td><td>Computation</td><td><div class="method-code">SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.VISNUMEN" class="tableroweven"><td>Algorithm to derive ADSL.VISNUMEN</td><td>Computation</td><td><div class="method-code">if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'</div></td></tr><tr id="MT.MT.ADSL.WEIGHTBL" class="tablerowodd"><td>Algorithm to derive ADSL.WEIGHTBL</td><td>Computation</td><td><div class="method-code">VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3</div></td></tr><tr id="MT.MT.ADTTE.ADT" class="tableroweven"><td>Algorithm to derive ADTTE.ADT</td><td>Computation</td><td><div class="method-code">if ADAE.ASTDT is not missing and occurred after TRTSDT then ADAE.ASTDT else convert ADSL.RFENDTC to a SAS numeric date</div></td></tr><tr id="MT.MT.ADTTE.AVAL" class="tablerowodd"><td>Algorithm to derive ADTTE.AVAL</td><td>Computation</td><td><div class="method-code">ADT-STARTDT+1</div></td></tr><tr id="MT.MT.ADTTE.CNSR" class="tableroweven"><td>Algorithm to derive ADTTE.CNSR</td><td>Computation</td><td><div class="method-code">if ADAE.TRTEMFL ="Y" then CNSR=0, else CNSR=1</div></td></tr><tr id="MT.MT.ADTTE.EVNTDESC" class="tablerowodd"><td>Algorithm to derive ADTTE.EVNTDESC</td><td>Computation</td><td><div class="method-code">if ADTTE.CNSR = 0 then "Dematologic Event Occured", else if ADTTE.CNSR =1 then "Study Completion Date"</div></td></tr><tr id="MT.MT.ADTTE.SRCDOM" class="tableroweven"><td>Algorithm to derive ADTTE.SRCDOM</td><td>Computation</td><td><div class="method-code">The Source domain referred to in order to populate ADT (either ADAE or ADSL)</div></td></tr><tr id="MT.MT.ADTTE.SRCSEQ" class="tablerowodd"><td>Algorithm to derive ADTTE.SRCSEQ</td><td>Computation</td><td><div class="method-code">The value of ADAE.AESEQ if SRCDOM=ADAE, otherwise null.</div></td></tr><tr id="MT.MT.ADTTE.SRCVAR" class="tableroweven"><td>Algorithm to derive ADTTE.SRCVAR</td><td>Computation</td><td><div class="method-code">The Source variable referred to in order to populate ADT (either ASTDT or RFENDT)</div></td></tr><tr id="MT.MT.ADVS.ADT" class="tablerowodd"><td>Algorithm to derive ADVS.ADT</td><td>Computation</td><td><div class="method-code">the date part of VS.VSDTC converted to a SAS date</div></td></tr><tr id="MT.MT.ADVS.ANL01FL" class="tableroweven"><td>Algorithm to derive ADVS.ANL01FL</td><td>Computation</td><td><div class="method-code">ANL01FL="Y" if the value is to be included in a per visit analysis. ANL01FL is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL"</div></td></tr><tr id="MT.MT.ADVS.AVISIT" class="tablerowodd"><td>Algorithm to derive ADVS.AVISIT</td><td>Computation</td><td><div class="method-code">Derived from VS.VISIT for values to be included in a per visit analysis. AVISIT is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL", which are not included in a per visit analysis.</div></td></tr><tr id="MT.MT.ADVS.BASE" class="tableroweven"><td>Algorithm to derive ADVS.BASE</td><td>Computation</td><td><div class="method-code">VS.VSSTRESN where VSBLFL="Y"</div></td></tr><tr id="MT.MT.ADY" class="tablerowodd"><td>Algorithm to derive ADY</td><td>Computation</td><td><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT&gt;=TRTSDT. ADY = ADT - TRTSDT, if ADT&lt;TRTSDT.</div></td></tr><tr id="MT.MT.ALBTRVAL" class="tableroweven"><td>Algorithm to derive ALBTRVAL</td><td>Computation</td><td><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr id="MT.MT.AVISITN" class="tablerowodd"><td>Algorithm to derive AVISITN</td><td>Computation</td><td><div class="method-code">Using window method in SAP Page 10 to determine AVISITN value based on ADY.</div></td></tr><tr id="MT.MT.BNRIND" class="tableroweven"><td>Algorithm to derive BNRIND</td><td>Computation</td><td><div class="method-code">ADLBC.ANRIND when ADLBC.ABLFL=Y</div></td></tr><tr id="MT.MT.CHG" class="tablerowodd"><td>Algorithm to derive CHG</td><td>Computation</td><td><div class="method-code">AVAL - BASE, for post baseline records.</div></td></tr><tr id="MT.MT.DTYPE" class="tableroweven"><td>Algorithm to derive DTYPE</td><td>Computation</td><td><div class="method-code">Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit.</div></td></tr><tr id="MT.MT.PCHG" class="tablerowodd"><td>Algorithm to derive PCHG</td><td>Computation</td><td><div class="method-code">100* (CHG/BASE), for post baseline records.</div></td></tr><tr id="MT.MT.SHIFT1" class="tableroweven"><td>Algorithm to derive SHIFT1</td><td>Computation</td><td><div class="method-code">Set to "High to Normal" if base=1 and aval=0.
Set to "Normal to Normal" if base=0 and aval=0.
Set to "Normal to High" if base=0 and aval=1.</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div></body></html>